Final EU medical device regulation amendment available
Date: 27 April 2020
The amendment document relating to the dates of application of the new medical device regulation MDR (EU) 2017/745, decided by the European parliament on 17 April 2020, has finally been published and is in force. It follows the proposal of the European Commission with some minor corrections, such as considering the Corrigendum from 25 November 2019, in which a shift was already granted for certain class I devices, for which the conformity assessment procedure requires the involvement of a notified body in future.
Proposal for the amendment of the Medical Device Regulation (EU) 2017/745 available
Date: 6 April 2020
On 3 April 2020, the proposal for the delay of the implementation of the new MDR has been published.
In the proposal, all dates referring to the original implementation date of 26 May 2020 have been replaced by 26 May 2021, with exception of the preparation of the guidelines on phthalates. In addition to keeping the requirements for existing devices, this allows placing new or modified medical devices on the market under the Directives 93/42/EEC and 90/385/EEC up to this new implementation date next year. The deadlines for placing the UDI on the device and packaging, which were scheduled further in the future, remain unchanged.
The proposal also suggests implementing Article 59 of the MDR (EU) 2017/745 prematurely, which allows the Commission to extend, in exceptional cases, the validity of a national derogation for a limited period of time to the territory of the EU. The national derogations in Article 59 are intended to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health.
European standards for medical supplies made freely available to facilitate increase of production
Date: 2 April 2020
Due to the Covid-19 crisis, the European Commission is working with industry and Member States to maximise the availability of masks, gloves, gowns and other medical supplies.
“Upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment. This action will help both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the internal market more easily while ensuring a high degree of safety”. (Press release of the European Commission)
The standards are available for free download from the websites of CEN national members.