Cases in which obligations of manufacturers apply to importers, distributors or other persons
1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a)
makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b)
changes the intended purpose of a device already placed on the market or put into service;
(c)
modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
(a)
provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
(b)
changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.
Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
(a)
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (36) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a)
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b)
the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c)
the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d)
the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e)
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.
5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.
6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:
(a)
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
1. This Regulation lays down rules concerning the
placing on the market, making available on the market or putting into service
of medical devices for human use and accessories for such devices in the Union.
This Regulation also applies to clinical investigations concerning such medical
devices and accessories conducted in the Union.
2. This Regulation shall also apply, as from the date
of application of common specifications adopted pursuant to Article 9, to
the groups of products without an intended medical purpose that are listed in
Annex XVI, taking into account the state of the art, and in particular
existing harmonised standards for analogous devices with a medical purpose,
based on similar technology. The common specifications for each of the groups
of products listed in Annex XVI shall address, at least, application of
risk management as set out in Annex I for the group of products in
question and, where necessary, clinical evaluation regarding safety.
The necessary common specifications shall be adopted by 26 May 2020.
They shall apply as from six months after the date of their entry into force or
from 26 May 2020, whichever is the latest.
Notwithstanding Article 122, Member States’ measures regarding
the qualification of the products covered by Annex XVI as medical devices
pursuant to Directive 93/42/EEC shall remain valid until the date of
application, as referred to in the first subparagraph, of the relevant common
specifications for that group of products.
This Regulation also applies to clinical investigations conducted in the
Union concerning the products referred to in the first subparagraph.
3. Devices with both a medical and a non-medical
intended purpose shall fulfil cumulatively the requirements applicable to
devices with an intended medical purpose and those applicable to devices
without an intended medical purpose.
4. For the purposes of this Regulation, medical
devices, accessories for medical devices, and products listed in Annex XVI
to which this Regulation applies pursuant to paragraph 2 shall hereinafter
be referred to as ‘devices’.
5. Where justified on account of the similarity between
a device with an intended medical purpose placed on the market and a product
without an intended medical purpose in respect of their characteristics and
risks, the Commission is empowered to adopt delegated acts in accordance with
Article 115 to amend the list in Annex XVI, by adding new groups of
products, in order to protect the health and safety of users or other persons
or other aspects of public health.
6. This Regulation does not apply to:
(a)
in vitro diagnostic medical devices covered by
Regulation (EU) 2017/746;
(b)
medicinal products as defined in
point 2 of Article 1 of Directive 2001/83/EC. In deciding
whether a product falls under Directive 2001/83/EC or under this
Regulation, particular account shall be taken of the principal mode of action
of the product;
(c)
advanced therapy medicinal products
covered by Regulation (EC) No 1394/2007;
(d)
human blood, blood products, plasma
or blood cells of human origin or devices which incorporate, when placed on
the market or put into service, such blood products, plasma or cells, except
for devices referred to in paragraph 8 of this Article;
(e)
cosmetic products covered by
Regulation (EC) No 1223/2009;
(f)
transplants, tissues or cells of
animal origin, or their derivatives, or products containing or consisting of
them; however this Regulation does apply to devices manufactured utilising
tissues or cells of animal origin, or their derivatives, which are non-viable
or are rendered non-viable;
(g)
transplants, tissues or cells of
human origin, or their derivatives, covered by Directive 2004/23/EC, or
products containing or consisting of them; however this Regulation does apply
to devices manufactured utilising derivatives of tissues or cells of human
origin which are non-viable or are rendered non-viable;
(h)
products, other than those referred
to in points (d), (f) and (g), that contain or consist of viable biological
material or viable organisms, including living micro-organisms, bacteria,
fungi or viruses in order to achieve or support the intended purpose of the
product;
(i)
food covered by Regulation
(EC) No 178/2002.
7. Any device which, when placed on the market or put
into service, incorporates as an integral part an in vitro diagnostic
medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746,
shall be governed by this Regulation. The requirements of
Regulation (EU) 2017/746 shall apply to the in vitro diagnostic
medical device part of the device.
8. Any device which, when placed on the market or put
into service, incorporates, as an integral part, a substance which, if used
separately, would be considered to be a medicinal product as defined in
point 2 of Article 1 of Directive 2001/83/EC, including a
medicinal product derived from human blood or human plasma as defined in point 10
of Article 1 of that Directive, and that has an action ancillary to that
of the device, shall be assessed and authorised in accordance with this
Regulation.
However, if the action of that substance is principal and not ancillary
to that of the device, the integral product shall be governed by
Directive 2001/83/EC or Regulation (EC) No 726/2004 of the
European Parliament and of the Council (34), as applicable. In
that case, the relevant general safety and performance requirements set out in
Annex I to this Regulation shall apply as far as the safety and
performance of the device part are concerned.
9. Any device which is intended to administer a
medicinal product as defined in point 2 of Article 1 of
Directive 2001/83/EC shall be governed by this Regulation, without
prejudice to the provisions of that Directive and of
Regulation (EC) No 726/2004 with regard to the medicinal
product.
However, if the device intended to administer a medicinal product and
the medicinal product are placed on the market in such a way that they form a
single integral product which is intended exclusively for use in the given
combination and which is not reusable, that single integral product shall be
governed by Directive 2001/83/EC or
Regulation (EC) No 726/2004, as applicable. In that case, the
relevant general safety and performance requirements set out in Annex I to
this Regulation shall apply as far as the safety and performance of the device
part of the single integral product are concerned.
10. Any device which, when placed on the market or put
into service, incorporates, as an integral part, non-viable tissues or cells of
human origin or their derivatives that have an action ancillary to that of the
device shall be assessed and authorised in accordance with this Regulation. In
that case, the provisions for donation, procurement and testing laid down in
Directive 2004/23/EC shall apply.
However, if the action of those tissues or cells or their derivatives is
principal and not ancillary to that of the device and the product is not
governed by Regulation (EC) No 1394/2007, the product shall be
governed by Directive 2004/23/EC. In that case, the relevant general
safety and performance requirements set out in Annex I to this Regulation
shall apply as far as the safety and performance of the device part are
concerned.
11. This Regulation is specific Union legislation
within the meaning of Article 2(3) of Directive 2014/30/EU.
12. Devices that are also machinery within the meaning
of point (a) of the second paragraph of Article 2 of
Directive 2006/42/EC of the European Parliament and of the Council (35) shall, where a
hazard relevant under that Directive exists, also meet the essential
health and safety requirements set out in Annex I to that
Directive to the extent to which those requirements are more specific than
the general safety and performance requirements set out in Chapter II of
Annex I to this Regulation.
13. This Regulation shall not affect the application of
Directive 2013/59/Euratom.
14. This Regulation shall not affect the right of a
Member State to restrict the use of any specific type of device in
relation to aspects not covered by this Regulation.
15. This Regulation shall not affect national law
concerning the organisation, delivery or financing of health services and
medical care, such as the requirement that certain devices may only be supplied
on a medical prescription, the requirement that only certain health
professionals or healthcare institutions may dispense or use certain devices or
that their use be accompanied by specific professional counselling.
16. Nothing in this Regulation shall restrict the
freedom of the press or the freedom of expression in the media in so far as
those freedoms are guaranteed in the Union and in the Member States, in
particular under Article 11 of the Charter of Fundamental Rights of the
European Union.
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