May 15, 2019

With the European Medical Devices Regulation (MDR) coming into force in less than one year, plus related challenges such as Brexit, Notified Body capacity and Eudamed database implementation, manufacturers of CE-Marked devices have a lot to track in order to maintain European market compliance.

To help companies familiarize themselves with the latest European market and regulatory developments, we’ve summarized Emergo by UL blog coverage over the past several months for your review.

MDR clinical requirements

One of the MDR’s most significant impacts for medical device manufacturers will be on their clinical investigation and data obligations:

  • MDR establishes new rules for clinical study investigator and site selection processes
  • Manufacturers should make early preparations to comply with MDR post-market clinical follow-up (PMCF) data requirements
  • How MDR will tie PMCF data more closely to post-market surveillance and clinical evaluation report (CER) requirements

Eudamed medical device database implementation

Manufacturers of CE-Marked devices anticipate having to begin entering Unique Device Identification (UDI) and related data into the European Eudamed database in 2020. Recent Eudamed-related coverage includes:

  • Five key questions from manufacturers on Europe’s Eudamed database
  • Clarifications from the European Medical Devices Coordination Group (MDCG) on Eudamed timelines
  • MDCG plans to adapt the Italian health ministry’s medical device codes for use as Eudamed database nomenclature

Notified Bodies, MDR and Brexit

MDR requirements as well as the potential realization of a no-deal Brexit withdrawal of the UK from the European Union in October 2019 are also changing relationships between CE Mark holders and their Notified Body (NB) partners:

  • British NB BSI became the first such entity to obtain designation under the MDR in early 2019
  • BSI has also established a Dutch NB, BSI-NL, to help clients ensure validity of their CE Mark certificates if and when Brexit goes into effect

Additional European medical device regulatory resources from Emergo by UL:

Author

  • Stewart Eisenhart

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