Current issue of “RMS NEWS”
NEWSTICKER 31.01.2024
- RECENT COMMITTEE NEWS
Update Q&A Medical Devices. The CMDh, in collaboration with EMA and the European Commission, has agreed on an update of the joint EMA/CMDh Q&As on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746). It was clarified that for MRPs or RUPs, the previously assessed documentation under the MDD for existing products can be accepted if there are no product-related significant changes to the integral DDC (drug-device combination) approved in the RMS since the entry into force of the MDR. A further, more comprehensive update of the questions and answers is currently in progress and will be published in the near future.
Data to be submitted for variations/renewals. The CMDh has revised the guidance document Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers with regard to the data to be submitted. The update takes into account the new standard renewal procedure, which was introduced in February 2023 and specifies whether the requirements for a renewal, a variation or both apply. It also lists those Member States that require a full documentation in standard renewal procedures under their national legislation. The existing national requirements have been reviewed by the Member States and reduced as far as possible.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
