legislation-profile

In Vitro Diagnostic Medical Devices Regulation

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

Scope

Regulation (EU) 2017/746 shall apply to in vitro diagnostic medical devices and their accessories. Pursuant to Article 1(4), the Regulation also applies to the in vitro diagnostic medical device when part of a device incorporates a medical device as defined in Article 2(1) of Regulation (EU) 2017/745. For the purposes of this Regulation the following definitions apply: 'Medical device' means that as defined in point (1) of Article 2 of Regulation (EU) 2017/745; 'in vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro as defined in Article 2(2). Please note that Regulation (EU) 2017/746 on in vitro diagnostic medical devices has repealed Directive 98/79/EC. The Regulation begins to apply from 26 May 2022. Nevertheless, Article 110 (3) and (4) provides for transitional periods, allowing in vitro diagnostic medical devices to be: 1/ placed on the market or put into service until various deadlines, under certain conditions related for example to the category of the device or the availability of a valid certificate from a notified body (some of the deadlines have been extended by Regulation (EU) 2022/112); and 2/ to be marketed for unlimited time, instead of the previous sale-off deadlines (as provided in Regulation (EU) 2023/607).

Exemptions

Exclusions are defined in Article 1(3) of the Regulation: a) products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; b) invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen; c) internationally certified reference materials; d) materials used for external quality assessment schemes.

Regulatory activities

1. Regulatory compliance In vitro diagnostic 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 performance evaluation in accordance with Article 56, conformity assessment procedure (Annexes IX to XI), technical documentation (Annexes II and III), EU harmonised standards (Article 8), summary of safety and performance for class C and D devices (Article 29), EU Declaration of conformity (Article 17), and CE-marking (Article 18). Pursuant to Article 15, manufacturers shall have available at least one person responsible for regulatory compliance. 2. Labelling requirements In vitro diagnostic medical devices are subject to specific labelling requirements and requirements related to the Instructions of use (Annex I, Chapter III - Requirements Regarding Information Supplied with the Device). In case of relabelling, additional requirements may apply to distributors, importers or other operators (Article 16). 3. Registration requirements Registration of in vitro diagnostic medical device by assigning UDI-DI (Article 26) and registration of manufacturers, authorised representatives, and importers (Article 28). 4. Post-market surveillance requirements In vitro diagnostic medical devices are subject to market and post-market surveillance requirements (Articles 78-96).

Relevant product types

In vitro diagnostic medical devices are divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks (VIII).

Reference documents

Yes Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (repealed) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (repealed) Directive 90/385/EEC on active implantable diagnostic medical devices (repealed) 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 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 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC 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 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 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare 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 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 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services 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

Obligations based on CLP hazard class

Yes 1. Design and manufacture requirements (Annex I, Chapter II, point 10.3 – Chemical, physical and biological properties): Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements are fulfilled. Particular attention shall be paid to substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), in accordance with Part 3 of Annex VI to the CLP Regulation (EC) No 1272/2008. 2. Labelling requirements and obligation to provide hazard communication (Annex I, Chapter III, point 20.1, letters i) and j)): In case of devices containing a substance or a mixture which may be considered as being hazardous, relevant hazard pictograms and labelling requirements of the CLP Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all information on the device itself or on its label, the relevant hazard pictograms shall be placed on the label and the other information required by the CLP Regulation (EC) No 1272/2008 shall be given in the instructions for use. Provisions of REACH Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all relevant information, as appropriate, is already made available in the instructions for use.

Obligations based on properties of concerns

Yes 1. Design and manufacture requirements (Annex I, Chapter II, point 10.3 - Chemical, physical and biological properties): Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements are fulfilled. Particular attention shall be paid to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of the REACH Regulation (EC) No 1907/2006.

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 30 (European database on medical devices) European database on medical devices (EUDAMED) 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

EUDAMED

Format for industry submission

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

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 77 and 108 - the EU Commission is empowered to adopt delegated or implementing acts, regulating specific aspects of medical devices.

Amendments

Corrigendum to Regulation (EU) 2017/746, OJ L 117, 3.5.2019 Corrigendum to Regulation (EU) 2017/746, OJ L 334, 27.12.2019 Regulation (EU) 2022/112, OJ L 19, 28.1.2022 Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 Regulation (EU) 2023/607 of 15 March 2023