Terms And Procedure For Communication On Placing On The Market, Distribution And Putting Into Service Of Medical Device And Informing Of Significant Changes Made Thereto


Published: 2011-03-20

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Terms and procedure for communication on placing on the market, distribution and putting into service of medical device and informing of significant changes made thereto

Passed 10.03.2011 Annex 10

The Regulation is established under subsection 26 (5) of the Medical Devices Act.

§ 1.  Scope of application

The present regulation establishes terms and procedure for communication on placing on the market, distribution and putting into service of medical device and informing of significant changes made thereto.

§ 2.  Information to be provided upon communication on placing on the market, distribution or putting into service of a medical device

(1) In the event of placing a medical device on the market, a custom-made medical device and a system of medical devices or a procedure pack of class I, the body placing the medical device on the market shall submit a notice complying with Directives 93/42/EEC and 98/79/EC on the form provided in the web page of the Health Board, including at least the following information:
1) name and address of the body placing the medical device on the market;
2) name and address of the manufacturer of the medical device and the authorised representative thereof (if applicable);
3) information identifying the medical device (commercial name, model, type, catalogue number, if applicable);
4) name in Estonian, intended purpose and class of the medical device;
5) GMDN (Global Medical Device Nomenclature) code of the medical device;
6) a copy of conformity declaration;
7) a copy of user manual;
8) a copy of labelling;
9) a statement in the event of a custom-made medical device.
(2) When communicating the placing on the market of an in vitro diagnostic medical equipment and a new in vitro diagnostic medical device the body placing the device on the market shall submit information regarding the reagents, reaction products, calibrators and control materials to the Health Board in addition to the information listed in section 1.
(3) When communicating the placing on the market of in vitro diagnostic equipment and self- testing medical devices belonging to A and B lists, the body placing the device on the market shall submit information to the Health Board regarding the analytical and diagnostic parameters of the device, if applicable, as well as the results of performance evaluation and certificates issued.
(4) For placing on the market, first-time distribution or first-time putting into service of a medical device of class II a, II b and III and an active implantable medical device in Estonia, the body placing the device on the market, distributing it or putting it into service shall submit a notice to the Health Board in form provided in section 1, including at least the following information:
1) name and address of the body placing the device on the market, distributing it or putting the medical device into service;
2) name and address of the manufacturer of the medical device and the authorised representative thereof (if applicable);
3) name of the medical device in Estonian;
4) information identifying the medical device according to clause 3 of section 1 of § 2;
5) a copy of the user manual;
6) a copy of labelling.
(5) A health care provider shall communicate the first-time putting of medical devices of class II b and III and active implantable medical devices into service and professional service in the institution, submitting the following information to the Health Board within 30 days from the putting of the device into service:
1) name and address of the health care provider;
2) name of the medical device in Estonian;
3) information identifying the medical device according to clause 3 of section 1 of § 2.
(6) The Health Board has a right to request additional information about the devices placed on the market, distributed, put into service and put into professional service.

§ 3.  Information to be submitted upon communication of significant changes

A body placing a medical device on the market shall inform the Health Board of significant changes made to a medical device placed on the market, which may influence the conditions of use or conformity of the device, and shall submit the following information:
1) nature of the change implemented;
2) description of the medical device;
3) amended user manual, if applicable.

§ 4.  Registration and retention of information and notification certificate

(1) The Health Board shall register the information obtained in an electronic database within 10 working days from the reception of the requested information, and shall issue a notification certificate upon the relevant request of the submitter provided in paragraphs 2 to 3, including the following information:
1) name of person having submitted the notice;
2) name of the manufacturer of the medical device and an authorised representative thereof (if applicable);
3) name of the medical device in Estonian;
4) information identifying the medical device according to clause 3 of section 1 of § 2;
5) reference number of the database.
(2) The notification certificate issued by the Health Board is valid for the placing on the market, distribution or putting into service all medical devices with the same identification information by the same person.
(3) The Health Board shall maintain the submitted information for at least 10 years from the date of issuing the notification certificate provided in section 1 of the present paragraph.

§ 5.  Administrative provisions

(1) Regulation No. 118 of the Ministry of Social Affairs “Terms and procedure for communication on placing a medical device on the market and informing of significant changes made thereto” (RTL 2004, 149, 2270; 2009, 99, 1482) from November 25th, 2004 is repealed.
(2) Section 5 of paragraph 2 shall enter into force on September 1st, 2011.

Hanno Pevkur
Minister
Juta Saarevet
Legal manager in the capacity of the chancellor

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