It feels very quiet in the medical device world. The quiet makes me ponder how all concerned parties (and there are many) are managing MDR compliance activities. It is not possible for all medical device products on the EU market to have a MDD certificate valid until 2024, therefore there must be a beehive of activity.

Across social media, regulatory associations and the World-Wide-Web, there remain promotions for a variety of free and fee-paid webinars, training sessions and consultative advice on how to interpret and interact within and around the regulation. A ground-breaking regulation that has been in effect for four years and in application of compliance for the past three months.

The European Commission, together with the Medical Device Coordination Group, continue to drip feed guidance to the medical device industry in an apparent act to convey what they actually meant when the regulation was written. No one outside the EC knows when a newly published guidance will require a 180 degree turnaround from their fundamental, resource intensive, costly and target driven plans.

However; the following predictions for an apocalyptic melt down of the medical device industry has not (yet) come to fruition:

  • Multiple device manufacturers closing up shop
  • Critical life-saving products snatched from the hands of EU healthcare professionals thus risking patient health
  • Products removed from the marketplace due to expiring certification and not enough notified bodies for conformity assessments
  • Number of importers decreasing and costs rising due to increased liabilities
  • Transferring initial registration targets to the US, thus stifling product innovation within Europe and depriving the EU population of new state of the art devices
  • And of course, one must mention Brexit, GB and Northern Ireland….

The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available in September 2021 (except for the mechanism for scrutiny and the clinical evaluation consultation procedure functionalities). Based upon roll out of the actor module, activation of the second and third modules is not anticipated to go very smoothly.

Were these doomsday prophecies falsely promoted by hand-wringing pessimists or are they yet to materialise to wreak havoc?

If you have an opinion to share on the state of play for the MDR or other legislation, I would love to hear from you.

For those of you who remain unsure as how to manage the globally required increase in data management efficiencies, regulatory operational support for compliance is just a click away at www.instem.com.

Do not get swept away in silence, we are here to assist you and provide a warm and welcoming shelter from the storm.

K Young

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