legislation-profile

Medical Devices Regulation

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Scope

The Regulation applies to medical devices and their accessories (both termed as 'devices'). Pursuant to Article 1(7), the Regulation also applies to in vitro diagnostic medical devices when incorporated in a medical device as an integral part. For purposes of the Regulation, 'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article, whether used alone or in combination as defined in Article 2 of the Regulation. The Regulation also applies to groups of products without an intended medical purpose (listed in Annex XVI). Please note that Regulation (EU) 2017/745 has repealed Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices. The Regulation began to apply from 26 May 2021. Nevertheless, Article 120 (3) and (4) allows medical devices with certificates issued by a notified body under the repealed Directives to be: 1/ placed on the market (or put into service) until various deadlines and under certain conditions related to quality management system or written agreement with a notified body; and 2/ to be marketed for unlimited time (instead of the previous sale-off deadline of 26 May 2025). These changes are introduced by Regulation (EU) 2023/607.

Exemptions

Exclusions are defined in Art. 1(6) of the Regulation: a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746; b) medicinal products covered by Directive 2001/83/EC; 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 Article 1(8); 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, except for 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, except for 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; and i) food covered by Regulation (EC) No 178/2002.

Regulatory activities

1. Regulatory compliance Medical devices may be placed on the market (or put into service) only if they meet the general safety and performance requirements set out in Annex I. Compliance is demonstrated through a clinical evaluation (Annex XIV), conformity assessment procedure (Annexes IX, X and XI), technical documentation (Annex II), EU Declaration of conformity (Article 19), and CE-marking (Article 20). Pursuant to Article 15, manufacturers shall have available at least one person responsible for regulatory compliance. 2. Labelling requirements Medical devices are subject to specific labelling requirements and requirements related to the Instructions of use (Annex I - Requirements regarding the Information Supplied with the Device). 3. Registration requirements Registration of medical device by assigning UDI-DI (Article 29) and registration of manufacturers, authorised representatives, and importers (Articles 30 and 31). 4. Post-market surveillance requirements Medical devices are subject to post-market surveillance requirements (Articles 83-101).

Relevant product types

Medical devices are divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks (Annex VIII).

Reference documents

Yes Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (repealed) Directive 90/385/EEC on active implantable diagnostic medical devices (repealed) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (repealed) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU Directive 2001/83/EC on medical products Regulation (EC) No 1223/2009 on cosmetic products Directive 2006/42/EC on machinery Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells 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 Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes Commission Recommendation of 18 October 2011 on the definition of nanomaterial Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Obligations based on CLP hazard class

Yes – Annex I, Chapter II (Requirements Regarding Design and Manufacture) For medical devices (including their parts and materials) that: 1) are invasive and coming into direct contact with the human body; 2) (re)administer medicines, body liquids or other substances to or from the body; 3) transport or store medicines, body fluids or substances to be (re)administrated to the body. 1. Design and manufacture requirements (Annex I, Chapter II, point 10.4.1): the specified devices, their parts and materials shall only contain CMR substances of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/200, in a concentration that is above 0,1% w/w, if justified by the reasons listed in point 10.4.2 2. Labelling requirements and obligation to provide information on residual risks (Annex I, Chapter II, point 10.4.5): if the specified devices contain CMR substances of category 1A or 1B and are used for treatment of children, pregnant or breastfeeding women, or other patient groups considered particularly vulnerable to these substances.

Obligations based on properties of concerns

Yes – Annex I, Chapter II (Requirements Regarding Design and Manufacture) For medical devices (including their parts and materials) that: 1) are invasive and coming into direct contact with the human body; 2) (re)administer medicines, body liquids or other substances to or from the body; 3) transport or store medicines, body fluids or substances to be (re)administrated to the body. 1. Design and manufacture requirements (Annex I, Chapter II, point 10.4.1): the specified devices, their parts and materials shall only contain endocrine disruptors with probable serious effects to human health, in a concentration that is above 0,1% w/w, if justified by the reasons listed in point 10.4.2 2. Labelling requirements and obligation to provide information on residual risks (Annex I, Chapter II, point 10.4.5): if the specified devices contain endocrine disruptors with probable serious effects to human health and are used for treatment of children, pregnant or breastfeeding women, or other patient groups considered particularly vulnerable to these substances.

EU-level occupational exposure limits

Not applicable

EU-level emission limit values

Not applicable

Substance-centric data source(s) at the EU level

Yes - Article 33 (European database on medical devices) EUDAMED (European database on medical devices) gives better access to information for the public and healthcare professionals and enhances coordination between the different Member States in the EU. It will integrate six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance. There may be additional data reporting requirements under other EU legal acts (for example, Article 9(1)(i) of the Waste Framework Directive 2008/98/EC requiring SCIP notification for articles containing substances of very high concern (SVHCs) at a concentration above 0.1% w/w)

Industry submission system in place

For EUDAMED database, data must be forwarded in a standardised format.

Format for industry submission

Owner

DG SANTE

Update process

DG SANTE, CEN/SENELEC Article 8 (Use of harmonised standards) - regarding European harmonised standards (EN standards), the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC) are the responsible organisations. Article 9 (Common Specifications) - 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 EU Commission may adopt common specifications in respect of the general safety and performance requirements set out in Annex I. Articles 114 and 115 – the EU Commission is empowered to adopt delegated or implementing acts, regulating specific aspects of medical devices.

Amendments

Corrigendum to Regulation (EU) 2017/745, OJ L 117, 3.5.2019 Corrigendum to Regulation (EU) 2017/745, OJ L 334, 27.12.2019 Regulation (EU) 2020/561, OJ L 130, 24.4.2020 Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 Regulation (EU) 2023/607 of 15 March 2023 Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 Regulation (EU) 2024/568 of 7 February 2024