EU MDR

Chapter 1 (Art 1 - 4) Scope and definitions

Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement

Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices

Chapter 4 (Art 35 - 50) – Notified bodies

Chapter 5 (Art. 51 – 60) Classification and conformity assessment

Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations

Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance

Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers

Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties

Chapter 10 (Art. 114 – 123) Final provisions

Annexes

Explore

Chapter 1 (Art 1 - 4) Scope and definitions

Article 1 - Subject matter and scope

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.

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 2021. They shall apply as from six months after the date of their entry into force or from 26 May 2021, 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.

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.

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’.

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.

This Regulation does not apply to:

in vitro diagnostic medical devices covered by

Regulation (EU) 2017/746⁠

;

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;

advanced therapy medicinal products covered by

Regulation (EC) No 1394/2007⁠

;

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;

cosmetic products covered by

Regulation (EC) No 1223/2009⁠

;

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;

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;

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;

food covered by

Regulation (EC) No 178/2002⁠

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.

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

Regulation (EC) No 726/2004⁠

of the European Parliament and of the Council (1), 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.

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

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.

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.

This Regulation is specific Union legislation within the meaning of Article 2(3) of

Directive 2014/30/EU⁠

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 (1) 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.

This Regulation shall not affect the application of

Directive 2013/59/Euratom⁠

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.

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.

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.

(1)

Regulation (EC) No 726/2004⁠

of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

⁠

⏳ Article 1(2) amended by

Regulation 2020/561⁠

⁠

Want to print your doc?
This is not the way.

Try clicking the ⋯ next to your doc name or using a keyboard shortcut (

CtrlP

) instead.