The European Commission has released and opened for consultation the first (English) version of the European Medical Device Nomenclature (EMDN).
This is an important step towards the implementation of the upcoming regulatory framework on medical devices (EU MDR & EU IVDR). The EMDN will be for ex. used by manufacturers for their medical device registration in EUDAMED and generally, it will provide support to all actors in the medical field by giving key device descriptions for all products available on the EU market and registered in EUDAMED.
As per Article 26 of the MDR and Article 23 of the IVDR, the new nomenclature is free of charge for manufacturers and other natural or legal persons required by the Regulation to use the nomenclature and where reasonably practicable also to other stakeholders.
Users and the broader healthcare community can provide their feedback and propose a new translation for an EMDN term description until 4 June 2021 through a submmission on the Commission web page.
Do you have a proposal for the English EMDN term description of your device? Have your say!
- MDCG 2021-1 Rev.1 Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional.
The MDCG has deleted the following sentence from third paragraph of the Guidance:
“Parties should also note that, in principle and unless otherwise concluded by the MDCG, the reporting obligations with regard to EUDAMED apply to all information generated and collected under the MDR from its date of application (e.g. UDI, certificates) and therefore must be carried out as soon as EUDAMED becomes fully functional.”
- Public consultation on Draft implementing regulation concerning online manuals replacing paper instructions
The European Commission has released a public consultation to guarantee the smooth implementation of the new Regulation EU 207/2012 concerning electronic instructions for use of medical devices.
All interested parties are welcome to submit their contribution until 25 May 2021.
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