Medical devices

Directive 93/42/EEC aims to protect the human health and safety, smooth operation of the single market and to achieve the results for which the devices are intended.

National authorities must ensure that all medical devices available in the EU are safe for patients, users and others when they are properly installed, maintained and used as they should be.

Legal act:
Regulation (EU) 2017/745 and Directive 93/42/EEC until 25/05/2020 (Partial end of validity)

Regulation (EU) 2020/561 amending Regulation (EU) 2017/745

Parts of Directive 93/42/EEC that remain active:
Regulation (EU) 2017/745, Article 122 - Repeal and Regulation (EU) 2020/561, Article 1.7

 

Consolidated act:
24/04/2020 of Regulation (EU) 2017/745

11/10/2007 of Directive 93/42/EEC

See Additional Resources tab.

Legal acts repealed by Regulation (EU) 2017/745:

Directive 93/42/EEC (Partial repeal from 26/05/2020)

Directive 90/385/EEC (Partial repeal from 26/05/2020, See Active implantable medical devices)

Legal acts repealed by Directive 93/42/EEC:

Directive 76/764/EEC

Previous guidelines:

Guidelines on Medical Devices - Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 93/42/EEC and 90/385/EEC - 12 October 2015

Guidelines on a Medical Devices vigilance system - January 2013

Additional Guidance Regarding the Vigilance System

Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment - OJ C 8 of 11 January 2021

Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 as regards common specifications for the reprocessing of single-use devices - OJ L 273/3 of 20 August 2020

Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 - June 2020

Guidance on regulatory requirements for medical face masks - June 2020

MDCG 2020-12 - Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues - June 2020

MDCG 2020-11 - Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC - 29 May 2020

Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies - OJ L 156 of 19 May 2020

MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 - May 2020

MDCG 2020-10/2 - Clinical Investigation Summary Safety Report Form v1.0 - May 2020

How to verify that medical devices and personal protective equipment - May 2020

MDCG 2020-9 Regulatory requirements for ventilators and related accessories - April 2020

Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions - April 2020

Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context - April 2020

Regulation (EU) 2017/745 posponed by one year

Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) - 11 March 2020

Update joint assessments for publication - Overview of the bodies at each stage of the process - March 2020

Medical Devices: Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices - June 2019

Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use medical devices - 2019

Statement of the Council’s reasons: Position (EU) No 2/2017 of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council 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 - C 116/197 - 11 April 2017

Medical Devices: Guidance document - Qualification and Classification of stand alone software - July 2016

Guidelines on Medical Devices - Clinical Evaluation: a Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC - June 2016