Nov 20, 2019

With the European Medical Devices Regulation (MDR) compliance a dominant topic at the Medica 2019 medical tradeshow in Düsseldorf, Germany, Emergo by UL consultants in attendance have presented an MDR readiness checklist whereby manufacturers can gauge their preparedness for the new Regulation.

Oliver Eikenberg, Ph. D., Senior RA/QA Consultant at Emergo by UL, discussed key elements of MDR compliance identified in the checklist (PDF download) during the Tech Forum component of the tradeshow.

“Identify your key concerns,” Eikenberg told the audience. “What are critical compliance aspects that need immediate attention? We only have six months left, and many companies have not started.”

MDR checklist items

The Emergo by UL MDR readiness checklist presented by Eikenberg covers a range of compliance issues such as quality management plans, supplier agreements, post-market activities and Notified Body partnerships:

  • Do you have a quality management plan in place for transition to MDR?
  • Do you have a post-market surveillance plan in place per MDR Annex III?
  • Is your product a device according to MDR criteria?
  • Does your device comply with new state-of-the-art EU standards?
  • Do you need to comply with MDR on the May 2020 deadline?
  • Have you updated your ER checklist according to GSPR requirements?
  • Do your quality agreements reflect MDR requirements for economic operators?
  • Are you prepared for UDI and Eudamed data entry rules?
  • Does your CER reflect MEDDEV2.7.1 rev 4 for clinical evidence?
  • Will your current Notified Body be designated to MDR?

 

Changes to how medical devices are classified under MDR pose a significant hurdle for manufacturers. MDR introduces a series of new terms—implant, reagent, prediction, prognosis—for which guidance is available from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers may access this guidance  to avoid last-minute compliance delays. A common thread throughout all these changes is a heightened sensitivity to risk under MDR.

“How many of the checklist questions have you answered with a ‘no’ or ‘not sure’?” Eikenberg asked the audience. “I highly recommend you focus on these areas and get support as appropriate for these elements…ready or not, we’ll need to be MDR-compliant in just a few short months.”

Additional European MDR compliance information from Emergo by UL: