UK MHRA to provide case-by-case grace periods to medical device manufacturers in need of new Notified Body partners

Stakeholder organizations are invited to nominate observers for work on Annex XVI devices

Progress report on Notified Body designations to MDR, IVDR issued by European Commission

What no Mutual Recognition Agreement between Switzerland and the EU could mean for medical device manufacturers post-MDR

Eudamed nomenclature clarifications in new European Commission guidance

How senior management can support RA/QA staff meet new clinical data requirements under the European Medical Devices Regulation

European cyber requirements under MDR, IVDR hew closely to IMDRF recommendations

Eight Notified Bodies now designated to Medical Devices Regulation (MDR).

Latest European MDCG guidelines cover MDR, IVDR sampling and coding criteria

The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards,...

NB capacity to support CE Mark certification under current Directives, future Regulations squeezed further.

New guidance clarifies PRRC role under the new Regulations

EMERGO BY UL SUMMARY OF KEY POINTS: European MDR clinical data requirements may impact up-classified medical devices as well as recertification of some devices. Manufacturers with CE Marked devices should be preparing post-market clinical follow-up (PMCF) studies now in order to comply with MDR requirements in 2020. Meeting the MDR’s PMCF requirements may impact some manufactures’ budgets in unforeseen ways.

EMERGO BY UL SUMMARY OF KEY POINTS: The European Medical Devices Regulation (MDR) will tie post-market clinical follow-up (PMCF) data more closely to post-market surveillance and clinical evaluation report requirements. Medical device companies’ PMCF studies will have to include specific components identified in the MDR. Approvals for PMCF studies will need to be obtained by Ethics Committees and, in some cases, Competent Authorities.