Regulatory Update: Final versions of EU MDR and IVDR released

The European Council released the final texts of the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) last month.  The below timeline is likely to follow:

  • Voting is set to begin – The European Council voted to accept the regulations on 7 March 2017, and the European Parliament will vote on 20 March 2017.
  • Formal publication – Following the votes, both regulations are expected to be formally published in late April or early May 2017.
  • Entry into force – After formal publication, the regulations will enter into force 20 days after publication.
  • Application of the new regulations – Given the transition timelines of three years for the MDR and five years for the IVDR, the new rules would apply in 2020 and 2022 respectively.

More than four years in the making and coming in at a massive 566 and 477 pages, both the MDR and IVDR will replace the EU’s existing regulatory framework for medical devices and in vitro diagnostic devices (IVDs) respectively.  The regulations will place tighter and more stringent requirements to ensure patient safety, as well as increased transparency and traceability along the entire supply chain.  They also aim to clarify and strengthen the powers of Notified Bodies.

Providing comment to RAPS for their story on the development, an EU official said, “The wording might have changed, but apart from corrections of some obvious mistakes and addition of necessary clarifications the new EU rules remain unchanged.”  According to the official, the content for both regulations is still the same as in the agreement approved by the Council on 20 September 2016.  The difference is that the new documents have undergone a legal-linguistic review to make sure that the texts are coherent and equivalent in all 24 official EU languages.

Over the coming months, LRQA will analyse the MDR and IVDR in detail and publish relevant updates for those impacted by the new regulations.

“In the meantime, LRQA is on track from a resource perspective and has already demonstrated this at our re-designation audit.  We will apply for MDR and IVDR re-designation from six months after entry into force, and intend to have full scope under the new regulations,” concluded Martin Penver, LRQA Head of Notified Body.

About LRQA’s Medical Device Expertise

With the constantly changing regulatory environment comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.

LRQA’s medical technical experts and industry specialists provide best-in-class medical quality assurance, CE marking product certification to MDD 93/42/EEC and IVDD 98/79/EC, and training services that will equip you with the relevant knowledge at any stage of the product life cycle, towards a timely market launch.

Through our extensive range of training and assessment services, LRQA is helping organisations worldwide remove the uncertainty associated with the changing medical regulatory landscape.  

For more information about our CE Marking and medical quality assurance services, email enquiries@lrqa.com or visit LRQA Medical Devices.

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