Key Benefits:
Law of 15 January 1970, dealing with medical devices
We JULIANA, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc., etc., etc.
All of them, who will see or hear these, saluut! do know:
In this regard, we have taken the view that it is desirable to regulate in the interests of public health as regards medical devices;
In this way, we, the Council of State, and with the mean consultations of the States-General, have been well-regarded and understood to be right and to be understood by the following:
1 The following shall be understood in this Act and the provisions which are based thereon:
a. 'medical device' means any instrument, apparatus or apparatus, any software or substance, or any other article, used alone or in combination, including any device and software required for its proper functioning, whether or not The manufacturer is specially designed for diagnostic or therapeutic purposes and is intended to be used by the manufacturer to be used in humans for:
-diagnosis, prevention, monitoring, treatment or alleviation of diseases,
-diagnosis, monitoring, treatment, alleviation or compensation of injuries or disabilities,
-research into, or replacement, or modification of the anatomy or of a physiological process,
-control of fertilization, where the main intended function in or to the human body is not achieved by pharmacological or immunological agents or by metabolism, but can be supported by such means;
b. having available: to deliver on delivery;
(c) apply: use of any function in the social service;
d. User: the person who pursues a medical device other than in the exercise of any function in social traffic;
e. Our Minister: Our Minister of Health, Welfare and Sport.
2 This Act does not apply to medicinal products.
In the interest of public health it may be decided, in the interest of public health, that it is prohibited to manufacture medical devices from a species designated by the measure:
a. without the authorisation of a central government body designated by the measure;
(b) other than in compliance with the rules laid down in or pursuant to the measure.
1 In the interest of public health, the general measure of management may lay down that it is prohibited to import, supply, supply or apply medical devices of a species designated for the purpose of the measure:
(a) if they do not comply with the requirements laid down in or pursuant to the measure;
(b) if they are not provided with proof that they have been approved by a service or body designated by or under the measure, or if they are not provided with proof that they are in conformity with a service or agency which Institution approved sample;
c. without a permit from a central government body designated by the measure;
(d) if the packaging does not comply with the requirements of the measure or imposed by the measure;
(e) if the requirements of the measure have not been complied with or taken under the measure, either on or on the basis of the product or on the packaging thereof, of the data relating to the product;
f. other than in compliance with the other provisions laid down in or under the measure.
2 In the case of application of the first paragraph, B It shall also be established by or pursuant to general management measures, the criteria to be used in the assessment and shall lay down rules on the proofs of approval. In such a case, further rules may also be laid down by or on the basis of a general measure of management, the assessment of which may be made and, in the case of a general measure of management, it may be laid down that, for the purpose of inspection, a health check in accordance with the (i) measures imposed are due.
In the case of a general measure of administration, public health may, in the interests of public health, be determined in respect of medical devices of a species designated by the measure:
a. That it is prohibited to deliver them to users;
b. that it is prohibited to deliver to users other than persons belonging to a category designated by the measure;
c. that it is prohibited to deliver them to users other than on a prescription from an expert, belonging to a category designated by the measure.
A general measure of management may, in respect of medical devices of a species designated for that purpose, which may constitute a serious risk to health, be determined, that it is prohibited to produce such products, to have, to be delivered or to be applied.
The draft general measure of management as referred to in one of the Articles 2 - 5 will be in the Official Gazette It is known The nomination of such a measure will not be done until after two months have elapsed since that publication.
1 If, in his judgment, the importance of public health is seeking an immediate supply, our Minister may arrange for the Articles 2 - 5 -
2 A decision adopted pursuant to paragraph 1 shall be taken into account in the Official Gazette known and expiring, except as a matter of earlier withdrawal, 12 months after its entry into force.
1 Our Minister may grant an application for a derogation from the Minister under one of the Articles 2 - 5 then pursuant to Article 7 Some.
2 Our Minister may delegate the power to him in the first member to any other institution of the central government to be designated by him.
3 A decision adopted pursuant to paragraph 2 shall be taken into account in the Official Gazette It is known
1 An authorisation or exemption may be granted under restrictions. Rules may be subject to a licence or a derogation.
2 Where rules are fixed under one of the Articles 2 - 5 , further rules may also be made in the case of, or under general management of, permits and exemptions. Where rules are to be determined pursuant to Article 7 Corresponding provisions may be taken in this respect.
3 It shall be prohibited to supply incorrect or incomplete information in respect of an application for authorization or exemption.
1 Our Minister shall designate, upon application, one or more of the institutions competent to draw up the procedures to be designated by him concerning the approval of the Article 3, first paragraph, point (b) .
2 A designated institution shall be empowered to carry out other persons to carry out the procedures to be carried out by the Commission in accordance with the instructions given by our Minister.
3 In the case of, or under general management, rules may be laid down concerning the grounds on which the designation may be given, withdrawn or amended.
4 To a designation may be connected.
Our Minister oversees the lawful and effective execution of the particular by or under this Law by virtue of Article 10 designated settings.
1 The following Article 10 Designated institutions shall, upon request, provide to our Minister, free of charge, the information required for the performance of his task. Our Minister may request access to information and documents in so far as it is reasonably necessary for the performance of his duties.
2 The following Article 10 Each year, the Agency shall send to our Minister a report on the work carried out by the institution in accordance with the designation and the legality and effectiveness of such activities and practices over the past year. With regard to this report, our Minister may lay down detailed rules.
1 Our Minister may be a Article 10 shall give general instructions to the institution in respect of the exercise of its task.
2 The institution is required to act in accordance with the instructions.
1 If, in the judgment of Our Minister, Article 10 the competent institution of the procedures referred to in the first paragraph of that Article shall not, or should not, be properly implemented, the Minister may take the necessary measures.
2 The provisions referred to in paragraph 1 shall not be affected earlier than after the institution concerned has been given the opportunity to submit the procedures to be followed by the institution concerned. 2. shall be properly implemented.
An interested party may appeal to our Minister against a decision on approval.
Within five years of the entry into force of the law in which this article has been inserted into this law, our Minister shall send to the States-General a report on the effectiveness and effectiveness of the functioning of the the under Article 10 designated settings.
1 The costs associated with the aid to or under this Law by Our Minister or by it on the basis of Article 8, second paragraph , designated other central government body, or as a result of the Article 3, first paragraph Rules laid down, work carried out and documents issued may be charged to the person for whom the work is carried out or the documents are issued.
2 The amounts to be reimbursed for the costs shall be determined by means of a ministerial arrangement.
1 With the supervision of compliance with or under this Act, the officials of the State Supervision designated by the decision of Our Minister, and other officials with regard to medical care, shall be responsible for the supervision of the devices of a kind designated by that decision.
2 Of a decision referred to in paragraph 1 shall be communicated by means of a decision of the Official Gazette .
Public health officials are empowered to impose a charge under administrative coercion in order to maintain an order as intended. Article 12a , and the Article 5:20, 1st paragraph, of the General Law governing the administrative law obligation.
Public health officials shall be empowered to give an order to suspend or terminate trade, import, export or delivery of a medical device in order to prevent damage to public health, and to have a medical device taken from the market.
1. He who prides an object-whether or not a medical device-as being suitable for one of the following: Article 1 (a) (a) If he knows or has reasonable grounds to suspect that the intended fitness is lacking or if the actual fitness to a serious extent remains in the case of the declarable, it shall be punished with imprisonment of up to two years. years or a fine of the fourth category.
2 With equal penalty, he shall be punished with an object, whether or not a medical device, as intended for use on the packaging or on a scripted text as appropriate for one of the institutions. Article 1 (a) (a) , indicated functions, sells, sells, delivers, leases, or disallows, while knowing or reasonably must suspect that the intended fitness is lacking or actual fitness is in serious condition. Leach left behind.
3 The offences which are punishable in the preceding paragraphs are criminal offences.
Our Minister has the power to impose an administrative fine of up to € 900 000 on a conduct contrary to the provisions of, or on the basis of, the Article 2 , 3 , 4 , 5 , 7, first paragraph , 9, first or third Member , or 13 .
1 Article 1 of the Law on Economic Crimes shall be amended so as to act or fail to comply with the rules laid down in, or pursuant to, Articles 2, 3, first paragraph, 4, 5, 7, first paragraph, 9, first and third paragraphs, and 12, first paragraph, of the Medical Devices Act, which provides for the offence to be violated as an infringement Article 6, first paragraph, below 4 °, of the Law on Economic Crimes is qualified.
2 Our Minister of Justice is in charge of the adaptation of Article 1 of the Law on Economic Crimes in accordance with the provisions of the preceding paragraph. The decision to this effect shall be taken into account in the State Sheet placed.
1 This law may be cited as: Law on medical devices.
2 She shall enter into force on a time to be determined by Us.
Burdens and orders, which are in the State Sheet will be placed, and that all Ministerial Departments, Authorities, Colleges and Officials, who so concern, will keep their hands on the precise execution.
Given at Paleize Soestdijk, 15 January 1970
JULIANA.
The Secretary of State for Social Affairs and Public Health.
R. J. H. KRUISINGA.
Published the twenty-sixth of February 1970.The Minister of Justice, a.i.,
H. K. J. BEERNINK.
