News about GMP/cGMP

25.06.2019

EU MDR/IVDR: Everything on its way?

Across the EU, an increasing number of discussions are highlighting concern about the challenges facing each stakeholder in the sector (manufacturers, notified bodies, authorised representatives, distributors, competent authorities, European Commission) in implementing the new MDR/IVDR Regulations on time and effectively.

The new MDR (2017/745/EU) is due to become fully applicable in May 2020. With this date being less than a year away, it’s time for check up’s on the status of preparedness both at Member State and at European level.

Much of the concern raised by the Medical Device Industry in Europe to date relates to the availability and capacity of notified bodies for medical devices under the new Regulation. German and Irish delegations have also addressed this concern to the Council of the European Union. With only one year to go, today only 2 (BSI UK and TÜV Süd, DE) out of nearly 60 NB’s have been notified. So far approximately 20 NB’s are expected to be available by the end of 2019. Meanwhile, two NBs – Lloyd's Register Quality Assurance, London and Swiss NB QS Zürich AG – made the announcement to not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR). But there are many other challenges across the Regulations that include:

  • System requirements
  • Infrastructure
  • Secondary legislation

Fundamentally however, there is currently a lack of clarity and available guidance on many requirements of the regulation and what the expectations of the regulatory system will be.

MedTech Europe has presented a solution-focused 7 point plan for accelerating implementation. Seven critical areas are identified and a call to action to the EC and all Member States was framed:

  • Notified Bodies: Designate them faster!
  • Re-certification: Ensure the procedure works for all products!
  • Eudamed Database: Deploy the new database with workable IT specifications and implementation timelines!
  • (Quality) Guidance: Publish it in the most urgent areas!
  • Scientific Bodies: Rapidly establish the new expert panels and EU reference laboratories!
  • Acts: Publish the most-needed ones, including certain ‘system-critical’ common specifications!
  • Harmonised Standards: Ensure they are available in the highest-priority areas first!

To sum it all up, MedTech Europe states:

“European Commission and Member States need to move faster in order to get the new system ready on time. We recognize the shift to a new system is a major task. European solutions are needed ASAP to avoid market disruption”.


Source:

Council of the European Union: Comments of the Irish and German Delegations to MDR/IVDR

MedTech Euorpe: Presentation to a solution-focused 7 point plan

 



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