Rs 812.213 Ordinance Of 17 October 2001 On Medical Devices (Odim)

Original Language Title: RS 812.213 Ordonnance du 17 octobre 2001 sur les dispositifs médicaux (ODim)

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812.213 order on medical devices (ODim) on 17 October 2001 (State April 15, 2015) the Swiss federal Council, having regard to art. 2, al. 2, 4, al. 2, 45, al. 3, 46, al. 2, 47, al. 2, 48, 49, al. 2, 50, al. 1, 51 and 82 of the Act of 15 December 2000 on therapeutic products (ATP), under art. 21, ch. 2, of the law of June 24, 1902 on electrical installations, under art. 9, al. 1, let. (b), of the Federal Act of 9 June 1977 on metrology, under art. 4, al. 1, of the Federal law of June 12, 2009, on the safety of products, having regard to art. 37 of the law of 22 March 1991 on radiation protection, in accordance with the Federal law of 6 October 1995 on technical barriers to trade, stop: Section 1 provisions general article 1 medical devices by medical devices, shall mean all the instruments, apparatus, equipment, software, substances, accessories and other medical utensils, used alone or in combination, including the software intended to be used specifically for diagnostic or therapeutic and necessary for the proper functioning of these: a. intended to be applied to humans; b. the principal intended action in or on the human body is not achieved by pharmacological means immunological or metabolic, but whose action can be supported by these means. etc. which are: 1. to recognize, prevent, monitor, treat, or mitigate diseases, 2 to recognize, monitor, treat or mitigate injuries or disabilities or to compensate for handicaps, 3. to analyze or to change the anatomical structure, to replace parts of the anatomical or analyze structure, modify or replace a physiological process, 4. to regulate the design or make diagnoses related to design.

Medical devices are divided into: a. classical medical devices; b. diagnostic medical devices in vitro; c. active implantable medical devices.

By diagnostic medical devices in vitro, means all the reagents, reagent products, calibration materials, control materials, kits, instruments, apparatus, equipment or systems intended to be used in vitro for the examination of specimens derived from the human body, including donations of blood and tissues, and used solely or mainly for the purpose of providing information: a. concerning the States physiological or pathological; b. concerning congenital anomalies; c. to determine the safety and compatibility with potential recipients; d. allowing the control of therapeutic measures.

Active implantable medical devices, means all medical devices: a. whose operation depends on a source of power or any other source of energy not generated directly by the human body or gravity; b. that are designed to be implanted, in whole or in part, by surgically or medical in the human body or by an intervention into a natural orifice; etc. which are intended to remain in place after the procedure.

Medical devices, means all medical devices that are of diagnostic medical devices or active implantable medical devices in vitro.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 1aDispositifs on measurement devices are medical devices that are manufactured for a particular patient.
They must be designed according to the written prescription and under the responsibility of a qualified person.
The conformity assessment procedure is carried out according to annex 3.
Medical devices manufactured in series that must be adapted to meet the specific requirements of the duly qualified person that uses are not considered to be custom-made devices.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. (2) exceptions classical medical devices and active implantable medical devices obtained from human tissue devitalized or containing such fabrics are only subject to the art. 6, al. 3, 26 and 27 as well as section 5.
With regard to classical medical devices and active implantable medical devices, the this order does not apply: a. to human blood, the products of human blood, human plasma or blood cells of human origin or to devices which, at the time of their placing on the market, contain blood, blood products, blood plasma and the blood cells of human origin unless it is of substances which, used separately, are considered to be components of drugs or as the human medicinal products derived from blood or plasma within the meaning of art. 1 of directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code relating to medicinal products for human use and which can produce an effect on the human body in addition to operative; b. organs, tissues or cells viable human or standardized transplants; c. organs, tissues or cells of animal origin except when it comes to medical devices manufactured from tissues devitalized animal or devitalized tissue of animal origin products.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 311, 28.11.2001, p. 67. as amended by directive 2009/53/EC, OJ L 168, 30.6.2009, p. 33. The texts of directives or regulations mentioned in the present O can be obtained from the Swiss Centre of information for technical rules (switec), Association Switzerland for Standardization (SNV), SNV 29, 8400 Winterthur (tel.: 052 224 54 54, Internet: www.snv.ch).
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 3 definitions for the purposes of this order, means: a. accessory: any component that, while not being a medical device in itself, must, according to the use for which it was intended the manufacturer, be used with a medical device according to the instructions of the manufacturer of the said device; b... .b. medical device manufactured in the facility: a medical device whose use is intended that in the establishment that has manufactured it or in a partner institution integrated with assurance of the quality of the system manufacturer; b. system and processing unit: Assembly of several classical medical devices for which features supplier's declarations of conformity corresponding and intended for employment provided for by the head of the first placing on the market; v. performance evaluation: any investigation to establish proof that a medical diagnostic device in vitro meets the performance required under normal conditions of use; (d). serious incident : any event related to the malfunction of a medical device or modification of its essential characteristics, labelling or the instructions inadequate, which resulted or could result in death or seriously impair the health of patients, users or third parties; e. State Contracting: State which has concluded with the Switzerland a convention of international law relating to the mutual recognition of assessments and related medical devices compliance procedures; f. State Third: State which has not concluded with the Switzerland a convention of international law on the mutual recognition of assessments and compliance procedures for medical devices.

For the first time on the market takes place when a new product or a product that has undergone a reprocessing or alteration of such kind that it serves more to the intended purpose or does more expected performance and that it is delivered or transferred the first time in Switzerland for consideration or not. Is also considered a first placing on the market use by professionals of a medical device imported directly from a third country or of a medical device manufactured in the facility.

Repealed by the c. of o. March 24, 2010, with effect from the 1 Apr. 2010 (2010 1215 RO).
Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
Introduced by c. I 5 of O on August 18, 2004, in force since Sept. 1. 2004 (RO 2004 4037).
Introduced by c. I 5 of O on August 18, 2004, in force since Sept. 1. 2004 (RO 2004 4037).
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

Section 2 requirements relating to the placing on the market of art. 4 requirements to be met by medical devices requirements within the meaning of art. 45, al. 2 ATP are: a. classical medical devices referred to in annex I to directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices (directive 93/42/EEC); b. medical diagnostic devices in vitro referred to in annex I to directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in diagnostic medical devices (directive 98/79/EC) vitro; c. the active implantable medical devices referred to in Annex 1 of Council directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (directive 90/385/EEC).


Active implantable and conventional medical devices which are also machinery within the meaning of directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending directive 95/16/EC (recast) shall meet the essential requirements of health and safety contained in annex I to this directive, if the latter are more specific than the essential requirements set out in the al. 1. the classical medical devices which, in addition to their use of medical device, are intended for use in accordance with the requirements on the personal protective equipment within the meaning of Council directive 89/686/EEC, of 21 December 1989 on the approximation of the laws of the States members relating to personal protective equipment, must also meet the essential health and safety requirements contained in this directive.
The essential requirements implemented by technical standards, common technical specifications, or the requirements of the pharmacopoeia are assumed fulfilled if the medical device is accordance with such standards, specifications or requirements.
The Swiss Institute for therapeutic products (Institute) establishes technical standards and common technical specifications to achieve the essential requirements to be met by medical devices; He published titles in the Federal worksheet, with mention of the organizations from which the texts may be obtained.
Are reserved with regard to the placing on the market of medical devices which are substances or which contain organisms, the provisions of the law of 7 October 1983 on the protection of the environment and the law of 21 March 2003 on genetic engineering.
The classification, packaging and labelling of diagnostic medical devices vitro and non-invasive conventional medical devices not directly coming into physical contact with the body are governed by the provisions of directive 99/45/EC of the European Parliament and of the Council, of 31 May 1999 on the approximation of the laws, regulations and administrative action in the Member States provisions relating to the classification packaging and labelling of dangerous preparations.

OJ L 169, 12.7.1993, p. 1, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.
OJ L 189, 20.7.1990, p. 17, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 157, 9.6.2006, p. 24, as last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.
Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 399, 30.12.1989, p. 18, amended last by the R (EC) no 596/2009, OJ L 188du 18.7.2009 p. 14 introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
Technical standards or to the medical electrical equipment, can be obtained from the Switzerland Association for Standardization (SNV), SNV 29, 8400 Winterthur, and electrical appliances for medical application, to the Swiss Association of electricians (ASE), Luppmenstrasse 1, 8320 Fehraltorf.
Common technical specifications may be obtained from SNV.
SR 812.211 SR 814.01 RS 814.91 new content according to Chapter 2 of annex 5 to the O from 10 sept. 2008 on the release in the environment, in effect since Oct. 1. 2008 (2008 4377 RO).
OJ L 200, 30.7.1999, p. 1 to 68, as last amended by R (EC) no 1272/2008, OJ L 353, 31.12.2008, p. 1.
Introduced by c. I 5 of 18 August 2004 (RO 2004 4037) O. New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 5Classification responsible for first placing on the market assigns classical medical devices classes I, IIa, IIb and III according to the risks they may present, taking into account the employment for which they are intended. This classification must comply with the provisions of annex IX to directive 93/42/EEC.
Any classification already done within the meaning of para. 1 can be resumed for imported medical devices of a Contracting State.

New content according to chapter I 5 W of 18 August 2004, in force since Sept. 1. 2004 (RO 2004 4037).
OJ L 169, 12.7.1993, p. 1, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
Adopted pursuant to the directive 93/42/EEC reclassifications are equally authentic for this order.
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 6 obligation to declarerla placing on the market of medical devices who, headquartered in Switzerland, puts on the market for the first time, in Switzerland or in a Contracting State, a medical device within the meaning of the let. to (c) must report to the Institute its name, address and a description of the devices concerned, and no later than at the time of the placing on the market: a. classical medical devices in class I; b. custom-made devices made from medical devices classical or active implantable; v. systems and processing units.

Anyone, headquartered in Switzerland, puts on the market for the first time, in Switzerland or in a Contracting State, a medical diagnostic device vitro shall declare to the Institute no later than at the time of placing on the market: a. its name and its address; b. the device to be placed on the market, including general indications related to its technology and its use; c. for devices referred to in annex II directive 98/79/EC and for self-testing devices: 1. the designation of the device, 2. all data allowing identification of the device, 3 performance according to annex I, section A, c. 3 characteristics, of directive 98/79/EC, 4. the results of the assessment of its performance, 5. the certificates of conformity.

It is only necessary to declare medical diagnostic devices vitro made in the establishment when it comes to medical devices referred to in annex II to directive 98/79/EC. If it products within the meaning of Schedule A to this annex, is required to attach to the documents referred to in the al. 2, let. c proof his accreditation, approval or recognition: a. If preferred manufacturer has been designated national reference laboratory is a laboratory with equivalent qualifications; ETB. If no common technical specification exists for the medical device concerned.

Anyone who puts on the market in Switzerland a medical device within the meaning of art. 2, al. 1, shall declare to the Institute no later than at the time of the placing on the market: a. its name and its address; b. the device intended to be placed on the market, including general indications related to its technology and its use.

The changes to the data referred to in the al. 1 to 3 must be announced in block at the Institute, once per year.

New term according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO). It was taken into account this mod. throughout the text.
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 7 product information product information is subject to the: a. classical medical devices by ch. 13 of annex I to directive 93/42/EEC; (b) active implantable medical devices by c. 14 and 15 of annex 1 to directive 90/385/EEC; c. diagnostic medical devices in vitro by ch. 8 of annex I to directive 98/79/EC.

Product information must be written in the three languages. The use of symbols, realized by harmonised standards, in lieu of written texts is allowed.
Information on the product can be drafted within three official languages, or even only in English, provided: a. that the medical device is intended to be given exclusively to professionals or whether it's a custom-made device or a medical device manufactured in the establishment; b. that the user has the technical and language skills necessary and make it agree with the language of drafting selected; v. that the protection of patients users and third parties is nevertheless ensured; ETD. that this does not harm the effective and efficient operative use.

On request, users must be able to receive additional information in one of the official languages.
When a product is not or not yet intended to be placed on the market as a medical device, but it can be confused with such a device, the texts must clearly and legibly indicate that this product is not a medical device and that it does not lend itself for medical purposes.

OJ L 169, 12.7.1993, p. 1, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.

OJ L 189, 20.7.1990, p. 17, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 8Marque of conformity and identification number medical devices placed on the market in Switzerland must bear a mark of compliance, in accordance with Annex 1. A mark of foreign conformity set out in annex 2 is also allowed.
No mark of conformity is required for: a. custom-made devices; b. products intended exclusively for demonstrations or exhibitions; c. the systems and processing units; d. products intended for clinical trials; e. products intended for the assessment of performance.

For medical diagnostic devices in vitro made in the establishment, a mark of conformity is only necessary if it is medical devices according to annex II of directive 98/79/EC. However, no mark of conformity is necessary for a product listed on list A of this Appendix: a. when the manufacturer institution has been designated as the national reference laboratory or is a laboratory with equivalent qualifications; ETB. When there are no common technical specification.

In addition to the mark of conformity medical devices whose conformity must be assessed by a conformity assessment body in annex 3 must have that body identification number. In the case of foreign marks of conformity, the Institute can accept, instead of the identification numbers, further details concerning the conformity assessment body.
The mark of conformity and, if applicable, the identification number should be included on the same medical device or, where this is not possible or appropriate, on the packaging and on the instructions for use and, if possible, on the sales packaging. Registration must be clearly visible, easily legible and indelible.
The Institute may issue identification numbers or the proxy signs within the meaning of the al. 4. new content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.

Section 3 s. conformity assessment Principle 9 anyone who places a medical device on the market in Switzerland must be able, upon request, produce the statement of compliance to the authorities responsible for control under the supervision of the market.
Anyone who, having its seat in Switzerland, puts on the market for the first time, in Switzerland or in a Contracting State, a medical device must be able to prove that its product complies with the essential requirements and that it presents well efficiency and the claimed performance.
The federal Department of the Interior (Department) may, in agreement with the federal Department of defence, protection of the population and sports, grant exemptions for medical devices intended exclusively to be put into circulation within the army or in the context of the specific tasks of the latter.
The Institute may, in individual cases, grant exemptions for non-compliant, provided medical devices: a. they serve to make a mortal danger or to remedy the sustainable degradation of a bodily function; b. no medical device is available for the indication concerned; etc that their use is limited to individual cases.

S. 10 procedure and certificate the procedure of conformity, certificate of compliance and declaration of conformity assessment are governed by Annex 3.
Case of a conformity assessment body, all information necessary for this evaluation must be provided to him.
Certificates modified, suspended or revoked by a conformity assessment body should no longer be used in their original form.

Section 4 s. conformity assessment bodies 11 conditions of conformity assessment bodies shall be: a. accredited by the Swiss Accreditation Service in accordance with the Ordinance of 17 June 1996 on the accreditation and designation (Akkbv) and, when an international agreement, designated as such by the Institute; OUB. .. .v recognized by Switzerland under an international convention.

The Institute means that the conformity assessment bodies that meet extra conditions laid down by the Akkbv, the conditions referred to in annex 3A. It evaluates to do the conformity assessment bodies concerned in detail; the evaluation includes an assessment on the spot.
The use of foreign bodies not recognized within the meaning of para. 1 is allowed if it can be shown with reality at the Institute: a. that the examination or applied conformity assessment procedure complies with the Swiss requirements. ETB. that the foreign body has a qualification equivalent to the qualification required in Switzerland.

The State Secretariat for the economy may order, in agreement with the Institute, bodies listed in the al. 2 or the certificates which they have issued are not recognized if the homologous Swiss bodies or the certificates which they have issued are not recognized by the State in which these foreign bodies are established. In so doing, it takes into account only the interests related to the policy of health, but also the interests of the national economy and external economic relations of the Switzerland.

New content according to chapter I of O of 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).
SR 946.512 repealed by the c. of o. from 1 Apr. 2015, with effect from 15 Apr. 2015 (2015 999 RO).
Introduced by the c. of o. from 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).

S. 11aduree, renewal and extension of the designation the designation shall be granted for a limited period not exceeding five years.
It may be renewed for periods not exceeding five years each. To do this, an application must be filed before the expiry of its period of validity.
The scope of the designation may, on request, be extended by the Institute.
The Institute shall the same assessments, including an assessment on-site, for renewal and for the extension of the scope of the designation for the designation. For the renewal of the appointment, it can also supervise an audit carried out by the conformity assessment body in the premises of one of its customers.

Introduced by the c. of o. from 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).

S. 11bCollaboration with the European Commission and the Member States of the European Union in the appointment procedure, including the renewal and extension of the designation, the Institute collaborates with the European Commission and States members of the EU according to annex 3 (b) where an international agreement provides.

Introduced by the c. of o. from 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).

S. 12validite decisions certificates and certificates issued by bodies of the conformity assessment procedures set out in annexes II, III, V and VI to directive 93/42/EEC, in annexes 2, 3 and 5 of directive 90/385/EEC and annexes III, IV, V and VII to directive 98/79/EC are valid for five years maximum. On request, the duration of the certificate may be extended by five years at most each time.
Conformity assessment bodies shall suspend, revoke, or limit any certificate issued by their care if the conditions are no longer fulfilled.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 169, 12.7.1993, p. 1, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 189, 20.7.1990, p. 17, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.

S. 13Obligation to declare and to notify conformity assessment bodies report to Institute all certificates issued, modified, supplemented, suspended, restricted, revoked or refused by their care by indicating the medical devices concerned.
Conformity assessment bodies shall report to other homologous organs all certificates suspended, revoked or denied by their care by indicating the medical devices concerned. On request, they provide information also on the certificates issued, modified, or complete, and give them more information on this subject.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 13acontrole of the Institute conformity assessment bodies controls the conformity assessment bodies according to art. 32 Akkbv and annex 3(c).
It may, at any time: a. conduct assessments on the spot, with or without notice; b. supervise audits carried out by the conformity assessment bodies in the premises of their clients.

Introduced by the c. of o. from 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).
SR 946.512 Section 5 Observation of products art. Autonomous 14controle


The head of the first placing on the market of a medical device in Switzerland or in a Contracting State shall take appropriate measures in order to, throughout the period of use indicated: a. identify the risks that could present the product; b. prevent potential hazards; c. draw the product.

It puts in place to this end an observation system and collect, for each device: a. claims; b. the experiments at the level of the use and effectiveness; c. the reports in the specialised press; d. its own analytical findings; e. corrective measures.

It must consider carefully the claims relating to the safety of the product and, where appropriate, carry out sample checks and take corrective action.
A person who subsequently makes a device on the market is required to contribute to compliance with safety requirements and participate in monitoring the safety of the device. It collects to this end claims and experiments concerning the use and effectiveness of the device and transmits it to the observing system.

New content according to c. I 7 of O on June 11, 2010, adapting O sector in the field of the safety of products, in force since 1 Jul. 2010 (2010 2749 RO).

S. 15declaration of serious incidents if the person responsible for the first placing on the market becomes aware of a serious incident in Switzerland, it is required to declare it to the Institute. Reports of serious incidents in a Contracting State should be addressed to the competent authority of the Contracting State concerned.
Anyone who finds, as a specialist, a serious incident during the use of medical devices must declare it to the Institute. The declaration may be made by a professional company.
The declaration must be made: a. If the incident represents or may pose, clearly and directly, a serious danger to the life or health of many persons: without delay, but in any case within two calendar days following its identification; b. If the incident resulted in the death or serious and unexpected interference to his health : without delay, but in any case within ten calendar days of the finding; c. in other cases: without delay, but in any case within 30 calendar days of the finding.

Hospitals put in place an internal reporting system obeying the principles of quality assurance, they designate a competent official, with proper technique, or medical training and shall inform the Institute; that person assumes the obligation to declare.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 3439 RO).

S. Summary 15adeclarations on request, the Institute can accept that the person responsible for the first placing on the market of a medical device periodically summary declarations surrender if the cause of the incidents is known or if, after the implementation of withdrawals and other security measures referred to in art. 15 c, products incorporating a defect are still on the market.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. trends 15bRapport if the person responsible for the first placing on the market finds, in the context of the observation of the products, a significant increase in the rate of incidents, it must report it to the Institute in a report of trends and to communicate the measures possibly taken.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 15cMesures regarding serious incidents if the head of the first put on the market becomes aware of a serious incident related to the use of a medical device, it will adopt internal measures as well as the security measures for the product placed on the market designed to reduce risk, such as the withdrawal, Exchange, modification, destruction or the sending of safety instructions for its use.
It prevents immediately Institute the withdrawal or other safety measures regarding the product placed on the market if it was manufactured in Switzerland, or if it is marketed. If the product has been manufactured or is marketed in a Contracting State, the declaration will be also sent to the competent authority of the State concerned.
The statement includes: a. all information identifying product; b. a full description of the risk the product; c. all available information regarding the identity of the person who supplied the product to the person responsible for the first placing on the market, and, unless he sold directly to users, persons to which he delivered it.

It is required to submit to the Institute, in an appropriate time, a final report on the measures taken and the effects.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
Introduced by c. I 7 of O on June 11, 2010, adapting O sector in the field of the safety of products, in force since 1 Jul. 2010 (2010 2749 RO).

S. 15dDevoir transmit information about withdrawals and other security measures anyone who has developed a medical device on the market is required to transmit, appropriately, to the users concerned and, where appropriate, to patients, withdrawals or other information security measures for this product.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 15eCollecte and evaluation of statements the Institute provides for the collection, evaluation and, where appropriate, transmission systematic statements.
He informed the cantons and the competent authorities of the Contracting States, as appropriate, serious incidents. He informed in all cases of withdrawals and other security measures for products placed on the market.
If necessary, the Institute publishes appropriately withdrawals and other security measures for products placed on the market.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

Section 6 special provisions concerning the use of medical devices arts. 16 medical prescription are subject to medical prescription medical devices for personal use likely to endanger human health, even if they are used in the rules of art, as well as medical devices containing drugs subject to medical prescription.
The Institute established by order a list of categories of medical devices subject to medical prescription.

S. 17 delivery delivery of medical devices must match the intended use and the information provided by the person responsible for the first placing on the market.
Medical devices subject to medical prescription, medical devices for personal use purchased self-service and not belonging to the class I medical devices of self-diagnosis in vitro may be returned only if the checkpoint is able to guarantee a specialised advice and that it meets the requirements for the operation.
Delivery to the public of medical devices for the diagnosis in vitro communicable human diseases is prohibited. The Institute may grant derogations in the interest of public health.
Delivery of diagnostic medical devices vitro made in the establishment is prohibited.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 18Utilisation medical devices intended to be used by professionals and groups likely to endanger human health when used in the rules of art are listed in annex 6.
The use of groups of medical devices listed in annex 6 is subject to the conditions specified in the annex in the operation and professional qualifications.
The Department is empowered to adapt annex 6 to technical developments and to add groups of medical devices intended to be used by professionals and likely to endanger human health when used in the rules of art.

New content according to chapter I 5 W of 18 August 2004, in force since Sept. 1. 2004 (RO 2004 4037).

S. 19Retraitement any professional several times using a medical device will ensure, before every reuse, to verify the functioning and ensure that the device has undergone a proper reprocessing.
Deemed reprocessing any measure of maintenance required to prepare for the intended use a medical device used or brand new, in particular activities such as cleaning, disinfection and sterilization.
Data relating to the process and validation of sterilization must be registered.
Anyone who retired for others of medical devices is required to prove that it succeeded a conformity assessment procedure according to annex 3 to the treatment and sterilization of medical devices.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 20 maintenance professional while using a medical device shall ensure its maintenance as well as associated are tests in accordance with legal requirements.

Maintenance must comply with the principles of quality assurance, be planned within the institution, and be carried out under appropriate conditions; It must be defined in function: a. instructions for maintenance of the person responsible for the first placing on the market; b. inherent risk to the considered device and its use.

The results of maintenance work and corresponding tests, defects and the dysfunctions observed as well as the measures taken to remedy must be recorded, and this for the following categories: a. active medical devices; b. medical devices with measurement function and that can be calibrated.

For medical devices with measurement function, the control procedures by order of 15 February 2006 on measuring instruments can be provided.

RS 941.210 new content according to chapter I of O of 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).

S. 20aModification any person who modifies or modified or refurbishes or making refurbish a medical device in a manner not consistent with the intended purpose, or so as to modify the performance must meet the requirements governing the first placing on the market.

Introduced by chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 21 advertising for medical devices intended for direct delivery to the public or to direct use by the public shall be limited exclusively to allegations including the information on the product with regard to its use, performance, and effectiveness.
Any misleading information regarding the effectiveness or performance of a medical device is prohibited.
It is forbidden to advertise to the public for medical devices: a. subject to medical prescription; b. intended to be used exclusively by professionals.

S. 22 import and export Institute may issue, on production of the evidence required, a certificate of export within the meaning of art. 50, al. 2, ATP for the export of medical devices to a third State.
It may issue, on production of the documents required, an import certificate if a third State requires evidence confirming that the relevant medical device is allowed to be placed on the market in Switzerland.
In duly justified cases, it can bind a certificate granting under certain conditions.
It revokes a certificate: a. If it was issued on the basis of fake documents; b. If the devices concerned no longer statements required compliance or the corresponding certificates of conformity or if they fall under the blow of a prohibition of import or export; c. If the medical device concerned presents a danger to the health of users, patients or third parties.

Section 7 control under s. market surveillance 23 principle control framework (subsequent control) market surveillance is designed to ensure that put medical devices on the market, the placing on the market, the observation procedures products and use of medical devices conform to the provisions of this order. The door later test also on medical devices that are placed on the market in a Contracting State by any person having its seat in Switzerland, similarly on the procedure of placing on the market and the observation said devices.
Subsequent testing is done by taking samples or as a result of serious incidents.

New content according to chapter I 5 W of 18 August 2004, in force since Sept. 1. 2004 (RO 2004 4037).

S. 24 bodies the Institute provides for subsequent testing of medical devices. The jurisdiction of other federal agencies or institutions is reserved with regard to certain aspects of this control.
The cantons are responsible later control: a. in retail and the points of call; b. the homemade devices to measure, as well as systems and processing units; c. maintenance and reprocessing of medical devices by professionals who use, except in hospitals.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 25 coordination body the Institute may set up a coordinating body. It: a. coordinating subsequent control and, where appropriate, verification of measurement functions of medical devices as well as the notification of the decisions taken by the various authorities; b. made office of information centre for any question or statement relating to medical devices; c. communicates to the bodies of subsequent testing in the case-by-case basis statements made in accordance with the procedure defined in art. 6. the authorities assuming implementation tasks in the field of medical devices are represented in the coordinating body. The Institute assumes the Presidency and the secretariat.
The other authorities assuming implementation tasks shall inform UNIDIR of their activities in relation to subsequent testing of medical devices.

New term according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO). It was taken into account this mod. throughout the text.

S. 26 awards in order to verify the conformity of medical devices, the organs responsible for the subsequent control may, free of charge: a. require evidence and information necessary; b. samples; c. do carry out checks; d. enter during the usual hours of work, the business premises of persons required to learn and to visit their installations; e. ask to see their records and require that these or additional information are written in one of the languages official or English.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 26aTraitement of personal data enforcement bodies are authorized to process the personal data they need to perform all the tasks conferred on them by this order. They can also handle health-related data, which are collected under the official supervision of market (articles 58 and 59 Heilmittelgesetz).
The processing of personal data is subject to the Federal law of June 19, 1992, on the protection of data.

Introduced by c. I 5 of O on August 18, 2004, in force since Sept. 1. 2004 (RO 2004 4037).
SR 235.1 s. 26bObligation collaborate and inform the person responsible for the first placing on the market of a medical device in Switzerland or in a Contracting State and any person who places the product later on the market are obliged to cooperate during execution. They must provide all information required for implementing bodies, as well as all necessary certificates and documents free of charge.

Introduced by c. I 7 of O on June 11, 2010, adapting O sector in the field of the safety of products, in force since 1 Jul. 2010 (2010 2749 RO).

S. 27 administrative measures if a medical device is not complying with the legal requirements, the competent authority shall notify the person responsible for the placing on the market the result of the control procedure and gives him the opportunity to speak on this subject. The authority may order measures. Where appropriate, it provides an appropriate period for their implementation.
If there is a founded suspicion that a device is medical, even complying with the legal requirements, presents an immediate danger and serious risk to the health or safety of patients, users or third parties, bodies concerned execution immediately take the necessary steps to remove the device from market, prohibit its placing on the market or put into receivership. The Institute then takes the necessary measures in accordance with art. 66 ATP. If required by the protection of the population, it takes measures in the form of a decision of general scope.

New content according to c. I 7 of O on June 11, 2010, adapting O sector in the field of the safety of products, in force since 1 Jul. 2010 (2010 2749 RO).

S. 27aModification of the federal Department of the Interior annexes may adapt the annexes to this order in the evolution of international standards or technical knowledge.
It performs the adaptations that may constitute technical barriers to trade with the agreement of the federal Department of the economy, training and research.

Introduced by the c. of o. from 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).

Section 8 provisions finals s. 28 repeal of the duty in force the following legal acts are repealed: a. the Ordinance of 24 January 1996 on medical devices; b. order of 24 February 1993 concerning diagnostic kits in vitro.

[RO 1996 987 1868, 1998 1496 c. I and II]
[RO 1993 967 1350, 1996 2348]

S. Transitional 29Dispositions of changing hospitals, March 24, 2010 implement their internal reporting system obeying the principles of insurance of the quality until July 1, 2011.
The cantons shall carry out control of maintenance and the reprocessing of medical devices by professionals who use from July 1, 2011.

New content according to chapter I of O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).

S. 30 entry into force


This order comes into force on January 1, 2002.

Annex 1 (art. 8, al. 1) mark of conformity the graphic representation of the mark of conformity is as follows: if compliance has been established by a review body, that body identification number is added next to the mark of conformity.

State April 15, 2015 Schedule 2 (art. 8, al. 1) the following conformity mark is defined in directives 93/42/EEC annex XII, 98/79/EC annex X and 90/385/EEC Annex 9. The graphic representation is informative.

If the compliance has been established by a review body, that body identification number is added next to the mark of conformity.

New content according to chapter III al. 2 O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 169, 12.7.1993, p. 1, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.
OJ L 189, 20.7.1990, p. 17, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.

State April 15, 2015 Schedule 3 (art. 10, para. 1) 1 conformity assessment procedures. The person responsible for the first placing on the market before the application of the conformity assessment procedure and the establishment of the declaration of conformity. Include definitions and procedures to be followed: a. in annexes 2 to 5 of the directive 90/385/EEC active implantable medical devices; b. in annexes II to X to directive 93/42/EEC for medical devices conventional; c. in annexes II to VIII of diagnostic medical devices directive 98/79/EC in vitro.

2. a conformity assessment body should be consulted: a. in accordance with the directive 90/385/EEC active implantable medical devices; b. pursuant to directive 93/42/EEC for classical medical devices of classes IIa, IIb and III; c. for medical self-diagnosis devices vitro; c. for medical diagnostic devices in vitro according to annex II of directive 98/79/EC even if they are made in the hotel (except for products according to ch. 3, let. b); d. for classical class I medical devices, whether they are sterile or with measurement function.

3. no conformity assessment body should be consulted for: a. other medical devices classical class I (non-sterile or without measuring function); b. medical diagnostic devices in vitro according to annex II of directive 98/79/EC, if: 1. the manufacturer institution has been designated as the national reference laboratory or is a laboratory with equivalent qualifications; et2. no common technical specification exists for this product.

b. for other medical devices for diagnosis in vitro that are not affected by ch. 2.c. all medical devices intended for clinical trials or evaluation of performance; d. custom-made devices.

4. If a provider assembles a system or a processing unit, it must produce a declaration stating: a. reciprocal component compatibility is established and has been verified in accordance with the instructions of the person responsible for the placing on the market; b. operating instructions, including those responsible for the placing on the market, are attached to the system or the processing unit etc. that all concerned activities subject to appropriate internal monitoring.

5 the conformity assessment of classical medical devices of class I: the conformity assessment shall be carried out in accordance with annex VII to directive 93/42/EEC; the declaration of conformity required must be established before the first placing on the market of the device.
6. assessment of the conformity of classical medical devices in class IIa: the conformity assessment must be carried out using one of the procedures laid down by directive 93/42/EEC, namely: a. the procedures of EC declaration of conformity according to annex VII to this directive, in conjunction with the procedure: 1 EC verification according to annex IV; 2. of EC declaration of conformity (production quality assurance) according to annex V, or 3. of EC declaration of conformity (product quality assurance) according to annex VI;

b. the procedure relating to the comprehensive system of quality assurance (EC declaration of conformity according to annex II to this directive); in such cases, ch. 4 of annex II is not applicable.

The declaration of conformity required must be established before the first placing on the market of the device.
7 Evaluation of conformity of classical medical devices in class IIb: the conformity assessment must be carried out using one of the procedures laid down by directive 93/42/EEC, namely: a. the procedure relating to the comprehensive system of quality assurance (EC declaration of conformity according to annex II to this directive); in such cases, ch. 4 of annex II is not applicable; b. the procedure CE type examination according to annex III to this directive, in conjunction with the procedure: 1 EC verification according to annex IV; 2. of EC declaration of conformity (production quality assurance) according to annex V, or 3. of EC declaration of conformity (product quality assurance) according to annex VI.

The declaration of conformity required must be established before the first placing on the market of the device.
8. Evaluation of the conformity of classical medical devices class III: the conformity assessment must be carried out using one of the procedures laid down by directive 93/42/EEC, namely: a. the procedure relating to the comprehensive system of quality assurance (EC declaration of conformity according to annex II to this directive); b. the procedure CE type examination according to annex III to this directive , in conjunction with the procedure: 1. EC verification according to annex IV, or 2. of EC declaration of conformity according to annex V.

The declaration of conformity required must be established before the first placing on the market of the device.
9. Evaluation of the conformity of the active implantable medical devices: the conformity assessment must be carried out using one of the procedures laid down by directive 90/385/EEC, namely: a. the procedure relating to the comprehensive system of quality assurance (EC declaration of conformity according to annex II to this directive); b. the procedure CE type examination according to annex III to this directive , in conjunction with the procedure: 1. EC verification according to annex IV, or 2. of EC declaration of conformity according to annex V.

The declaration of conformity required must be established before the first placing on the market of the device.
10 Evaluation of the compliance of custom-made devices and medical devices intended for clinical trials, all classes combined: the conformity assessment must be carried out according to the procedure defined in annex VIII to directive 93/42/EEC or for medical devices active implantable, according to annex VI to directive 90/385/EEC.
11 Evaluation of the conformity of all in diagnostic medical devices vitro, except for devices covered by Annex II to the directive 98/79/EC, the OBD devices and devices intended for performance evaluation: the conformity assessment must be carried out according to the procedure defined in annex III of the directive 98/79/EC. The declaration of conformity required must be established before the first placing on the market of the device.
12 the conformity assessment of medical devices for self-testing in vitro: the conformity assessment must be carried out according to one of the following procedures: a. According to annex III to directive 98/79/EC; b. According to ch. 13; c. According to ch. 14.

If it is carried out according to the procedure defined in annex III of the directive 98/79/EC, the design of the devices must be certified in accordance with Chapter 6 of this annex, by an examination this issued certificate by an organ of the conformity assessment and declaration of conformity required be established prior to their first placing on the market.
13 the conformity assessment of medical devices for diagnosis in vitro according to annex II, list B, of directive 98/79/EC: conformity assessment must be carried out using one of the procedures laid down by directive 98/79/EC, namely: a. the procedure relating to the comprehensive system of quality assurance (EC declaration of conformity according to annex IV to this directive); b. the procedure CE type examination according to annex V of this directive , in conjunction with the procedure: 1. EC verification according to annex VI, or 2. of EC declaration of conformity according to annex VII.

The declaration of conformity required must be established before the first placing on the market of the device.
14 the conformity assessment of medical devices for diagnosis in vitro according to annex II, list A, of directive 98/79/EC: conformity assessment must be carried out using one of the procedures laid down by directive 98/79/EC, namely: a. the procedure relating to the comprehensive system of quality assurance (EC declaration of conformity according to annex IV to this directive); b. the procedure CE type examination according to annex V of this directive in association with the assurance of the quality of the production procedure specified in annex VII.

The declaration of conformity required must be established before the first placing on the market of the device.
15 the conformity assessment of medical devices for diagnosis in vitro intended for the assessment of performance:

The conformity assessment shall be carried out according to the procedure laid down in annex VIII to directive 98/79/EC. A statement must be established in accordance with annex VIII to directive 98/79/EC before the assessment of performance.
16 the conformity assessment of medical diagnostic devices vitro made in the establishment: shall be issued for the device a declaration containing the following data: a. product identification; b. name and address of the establishment manufacturer; c. statement that the product meets the essential requirements.

The manufacturer should have a system of quality assurance appropriate, in accordance with recognized national and international standards (e.g. good laboratory practice of Microbiology and serology within the meaning of the Ordinance of 26 June 1996 on laboratories of Microbiology and serology, European standard EN ISO/IEC 17025 2000 [General requirements for the competence of testing and calibration laboratories] or EA-04/10) (: 2002 [Accreditation for Microbiological Laboratories]).
The documentation concerning the device must prove that it complies with essential requirements of annex I to directive 98/79/EC and that it presents good claimed performance.
For medical devices referred to in annex II to directive 98/79/EC, such a procedure cannot be carried out only: a. If preferred manufacturer has been designated national reference laboratory is a laboratory with equivalent qualifications; b. If it is a product on the list A of this annex; etc. If no common technical specification does exist.

17 Evaluation of compliance during the reprocessing of medical devices by third parties: a. shall be issued to retired operative a declaration containing the following information: 1. identification of the product; 2. name and address of the company through reprocessing; 3. that the product has been restated according to the instructions of the head of the first placing on the market, or declaration that a risk analysis and a validation procedure provided evidence that the own reprocessing procedure used offers the same guarantees of effectiveness and safety.

b. the company through reprocessing must have an insurance system of adequate quality, in accordance with accepted national or international.c. The documentation for reprocessing must prove that the device has been restated in accordance with the let. a, c. 3.

Updated according to ch. I 5 W of 18 August 2004 (RO 2004 4037) and ch. III al. 1 W of March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 189, 20.7.1990, p. 17, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 169, 12.7.1993, p. 1, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.
RS 818.123.1 State April 15, 2015 annex 3a (art. 11, Al 1) Conditions of designation of the bodies of the conformity assessment only conformity assessment bodies which meet the conditions set out in annex I of the implementing Regulation (EU) No 920/2013 may be designated.

Introduced by c. O II from 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).
R ex. (EU) No 920/2013 the Commission of 24 seven. 2013 concerning the designation and monitoring of notified bodies in respect of directive 90/385/EEC of the Council concerning active implantable medical devices and Council directive 93/42/EEC concerning medical devices, OJ L 253, the 25.9.2013 version, p. 8.

State April 15, 2015 3B (s. 11 (b)) together with the European Commission and the Member States of the European Union, a representative of the European Commission and representatives of two EU Member States designating authorities may participate in evaluations of conformity assessment bodies made by the Institute, including evaluations on-site. They have access to the documents necessary to evaluate the bodies concerned.

Introduced by c. O II from 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).

State April 15, 2015 annex 3 c (art. 13 a) oversight of the Institute conformity assessment examines assessments made by conformity assessment bodies, conducts evaluations on-site and supervises audits: a. at least once every 12 months: for the bodies of the conformity assessment with more than 100 customers; b. at least once every 18 months : for other conformity assessment bodies.

Introduced by the O ch.II the 1 Apr. 2015, in force since 15 Apr. 2015 (2015 999 RO).

State April 15, 2015 annex 4 equivalence of terms used in the ODim and the terms used in the annexes to directives 90/385/EEC, 93/42/EC 98/79/EC in order to correctly interpret the annexes to directives this which returns this order, it will take into account the following equivalences: term EC term equivalent in ODim organization notified directive conformity assessment body 80/181/EEC order of 23 November 1994 on units reporting this (annex compliance II, complete quality assurance system) declaration of conformity relating to the complete system of the person in charge according to the art quality assurance. 14, by. 2, of directive 93/42/EEC responsible for the first placing on the market agent responsible for the first placing on the market authority Swiss Institute therapeutic products, Bern design (devices) design (devices) certificate of EC type-examination certificate new content type examination according to ch. III al. 2 O on March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
OJ L 189, 20.7.1990, p. 17, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 169, 12.7.1993, p. 1, as last amended by directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
OJ L 331, 7.12.1998, p. 1, last amended by R (EC) no 596/2009, OJ L 188, 18.7.2009, p. 14.
OJ L 39 of the 15.02.1980. p. 4.
RS 941.202 State April 15, 2015 annex 5 repealed ch. III al. 3 of O on March 24, 2010, with effect from the 1 Apr. 2010 (2010 1215 RO).

State April 15, 2015 annex 6 (art. 18) 1. Groups of medical devices only doctors and professionals with training in accordance with the provisions of this annex and operating under the supervision and responsibility of a physician are entitled to use the following medical devices groups: a. injection devices intended to stay more than 30 days in the body human (long devices duration); b. the lasers of class 4 according to EN 60825 - 1: 1994 and its amendments A1: 2002 and A2: 2001 (lasers from) high power) .v light sources pulsed and non-coherent high power, such as high-power flash lamps.

2 requirements of training a. long injection devices duration can be used by professionals for the benefit of a specialization in the field of injection devices and nursing graduates long-term as well as by the people for the benefit of training with a equivalent specialization; b. high-power lasers and pulsed and non-coherent high-power light sources can be used by educated professionals in cosmetics or the benefit of an equivalent title and by the people for the benefit of training and specialization equivalent, provided that they have a sufficient statement to handle the appliance; c. patients treated with lasers and high power light pulsed and non-coherent high power sources should receive medical assistance before and after the treatment.

Introduced by c. II al. 2 W of 18 August 2004 (RO 2004 4037). Updated according to ch. III al. 1 W of March 24, 2010, in force since 1 Apr. 2010 (2010 1215 RO).
This standard can be obtained from SNV, SNV 29, 8400 Winterthur.

State April 15, 2015

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