Medical Device Regulation date of application postponed
The European medical device regulation 2017/745 have been postponed one year later in order to avoid shortages in getting key products available on the market during the coronavirus pandemic. The Medical Devices Regulation (MDR) which was initially enforceable on 26 May 2020 will now become fully effective on 26 May 2021. The medical device directive and active implantable medical device directive will cease to be an option to obtain CE marking. The European Parliament press release can be found here.
The legislation, which aims to bring comparable safety controls and transparency to medical devices in a similar way as to those governing drugs, will replace Medical Device Directive (MDD) and active implantable medical device directive (AIMD).
The regulation entered into force since 25 May 2017 but there was a transition period until 26 May 2020. The rules will ensure manufacturers and authorities are more liable for performing all the necessary assessments across a product’s lifecycle.
European Parliament approved a proposal from the European Commission to delay the full implementation of MDR with 693 votes to one, and two abstentions, on Friday (17 April 2020).
Why the EU Medical Devices Regulation has been postponed ?
The European Parliament stated: “Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight Covid-19, were they to follow the new rules of the Medical Devices Regulation from May this year. The European Parliament is therefore supporting the proposal to postpone the application of this regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.”