1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.
4. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
Implant card and information to be supplied to the patient with an implanted device
1. The manufacturer of an implantable device shall provide together with the device the following:
(a)
information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;
(b)
any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
(c)
any information about the expected lifetime of the device and any necessary follow-up;
(d)
any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.
In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.
2. Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.
3. The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.
1. Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article.
2. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC.
3. By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers’ obligations laid down in this Regulation provided that they ensure that:
(a)
the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied with;
(b)
the reprocessing is performed in accordance with CS detailing the requirements concerning: — risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing, — the validation of procedures for the entire process, including cleaning steps, — the product release and performance testing, — the quality management system, — the reporting of incidents involving devices that have been reprocessed, and — the traceability of reprocessed devices.
Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with.
Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available.
4. Member States may choose to apply the provisions referred to in paragraph 3 also as regards single-use devices that are reprocessed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to that health institution and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3.
5. The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by 26 May 2020. Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in in this Regulation. In the event that those CS are not adopted by 26 May 2020, reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body.
6. Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2020 in accordance with Directive 93/42/EEC, may be reprocessed.
7. Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out.
8. The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device.
The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
9. A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following:
(a)
the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing;
(b)
the making available or further use of reprocessed single-use devices.
Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available.
10. The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation.
1. When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.
2. Before making a device available on the market, distributors shall verify that all of the following requirements are met:
(a)
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b)
the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
(c)
for imported devices, the importer has complied with the requirements set out in Article 13(3);
(d)
that, where applicable, a UDI has been assigned by the manufacturer.
In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.
4. Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.
5. Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
6. Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.
1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
2. In order to place a device on the market, importers shall verify that:
(a)
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b)
a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
(c)
the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
(d)
where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
4. Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31.
5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer’s authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.
8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.
9. Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.
10. Importers shall cooperate with competent authorities, at the latters’ request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.
1. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.
3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
4. Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.
1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.
3. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
4. Devices that are manufactured and used within health institutions shall be considered as having been put into service.
5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:
(a)
the devices are not transferred to another legal entity,
(b)
manufacture and use of the devices occur under appropriate quality management systems,
(c)
the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,
(d)
the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
(e)
the health institution draws up a declaration which it shall make publicly available, including: (i) the name and address of the manufacturing health institution; (ii) the details necessary to identify the devices; (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,
(f)
the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;
(g)
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and
(h)
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.
This paragraph shall not apply to devices that are manufactured on an industrial scale.
6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
1. Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) of this Regulation.
2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
3. The Commission shall ensure that Member States share expertise in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products.
4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as relevant.
The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.
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.
Powered by TS Q&E - ISO 13485:2016 Medical Device Consulting Services
Manage Cookie Consent
We use cookies to optimise our website and our service.
Functional
Always active
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
Marketing
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
