The European Commission’s “State of play of joint Implementation plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR”, which was revised in July 2020, talks about submitting a new standards request to European standards bodies CEN and CENELEC in the first quarter of 2021.
CEN and CENELEC’s negative response to the Commission’s May 2020 standards request has caused a big problem for the industry. (als Pullquote) This is the second time the standards bodies have turned down a standards request in the framework of the EU medical devices regulation (MDR) and IVD Regulation (IVDR).
It seems, however, that the Commission is still confident that harmonised standards giving presumption of conformity to enable the conformity assessment of devices and their certification will be published in the Official Journal of the EU through implementing decisions from the first quarter of 2021. Communication between all parties is essential to avoid loosing more time seeing that the full application date of the MDR is 26 May 2021 and it dose not look possible that any MDR standards will be revised and adopted early enough for this date.
Source: Medtech Insight (an Informa product)
In order to receive more informations on Guidance Documents you might chose from the following options
- Read our article “Latest version of ISO 14971 on risk management and the MDR and IVDR“.
- Read our article “News on symbols to be used under the MDR and IVDR“.
- Read our paragraph “Major aspects of the MDR”.
- Read our article “Most important changes on MDR“.