|Council of the European Union, European Parliament
|Official Journal of the European Union
|L 117, Pages 1-175
|Legislation, News, Policy-making
Regulation (EU) 2017/745 - formally adopted by the co-legislators on 5 April 2017 - concerning the safety and performance of medical devices in the European Union. It is also known as the Medical Devices Regulation (MDR). This is a text with EEA relevance.
This Regulation updates the rules on placing on the market, making available and putting into service medical devices for human used and their accessories. It also contains rules on how clinical investigations concerning such devices and accessories are carried out in the European Union (EU). It introduces more stringent procedures for conformity assessment and post-market surveillance. It amends Directive 2001/82/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. It also repeals Council Directive 90/385/EEC and Council Directive 93/42/EEC.
The draft law was tabled by the European Commission on 26 September 2012 as part of a legislative package on the safety of medical devices. It was put forward in the aftermath of criticism relating the existing regulatory framework, particularly following scandals relating to metal-on-metal artificial hips and faulty silicone breast implants. Substantial divergence was noted in the interpretation and application of the rules, thus undermining the aims of the framework. Certain regulatory gaps and uncertainties were also detected with regard to certain products.
The plenary of the European Parliament adopted its negotiating position on 2 April 2014, followed by the Council of the European Union on 19 June 2015 (technical adjustments finalised in September 2015). An informal agreement between the co-legislators on the text for this draft law was reached on 25 May 2016. This endorsed by the Council on 7 March 2017 and the Parliament on 5 April. The Act was signed by the co-legislators on 5 April 2017 and published in the Official Journal on 5 May 2017. Its application started on 26 May 2021.
|Health, Internal Markets
|Consumer Rights | Protection, Medicines | Medical Devices, Public Health
|European Union [EU]