Medical device news
The European Commission’s extended transition period regarding in vitro diagnostic medical devices has come into force, and new guidelines have been issued regarding clinical evidence for in vitro diagnostic medical devices and regarding electronic instructions for use.
The deferred transition period
The European Parliament and the Council have published an extension of the existing transitional period in the regulation as regards in vitro diagnostic medical devices (IVDR).
The purpose of the extension is to ensure the smooth functioning of the internal market for in vitro diagnostic medical devices and to ensure a high level of protection of public health and patient safety during the gradual rollout of the IVDR.
The transitional provisions entered into force on 25 January 2022 and can be read here. The IVDR will still come into force on 26 May 2022.
On 14 December 2021, the European Commission adopted a new Implementing Regulation explaining the rules regarding the application of the Medical Device Regulation (MDR). The Implementing Regulation outlines the conditions under which information in the instructions for use of medical devices may be provided in electronic form (eIFU) instead of in paper form (IFU).
For this purpose, the Medical Device Coordination Group (MDCG) has prepared new guidance on the general principles of clinical evidence for in vitro diagnostic medical devices, MDCG 2022-2.
All the MDCG's guidance documents can be found here.
The status of the MDCG's ongoing guidance development can be found here.
Plesner will continue to monitor medical device developments.
You are welcome to contact us if you need advice in this area.