EU MDR is likely to be postponed due to Covid-19, but what about IVDR?

MedTech Europe has issued a statement welcoming the delay for enforcing the European Medical Devices Regulation (EU MDR), and asking for similar action for the In Vitro Diagnostic Regulation (IVDR).

The European Council and European Parliament of the European Commission have proposed deferring the 26^th May 2020 date of application by 12 months, to a new date of 26^th May 2021. This proposal will take legal effect when it is published in the EU Official Journal.

MedTech Europe commented on the postponed date: “The longer transition time will not change the full commitment the medical device industry is giving to ensure complete and swift implementation of the new regulation. As we have been doing since day one, our sector will continue to comply with all new requirements, so that the objectives of the regulation are met in full.”

The main reason for the amendment, is to allow the medical device industry to focus on the Covid-19 pandemic. According to MedTech Europe: “The sector’s number one priority right now is to supply safe and well-performing devices to patients, healthcare professionals and healthcare systems on the Covid-19 front line.”

Previously, there was concerns around the number of approved notified bodies, but this delay will provide more time for notified bodies to be designated and operational under the MDR.

IVDR is planned to come in to effect in May 2022, and MedTech Europe is also calling for this regulation to be delayed. The organisation said: “Whilst the IVDR foresees a longer transition period than that of the MDR, diagnostic manufacturers note that, even before the Covid-19 pandemic, very little progress had been achieved yet, to get the new IVDR regulatory system ready.

“For instance, well into the second half of the transition period, there are still only two to three notified bodies designated under the IVDR, and critically-needed IVDR guidance documents, on topics like performance evaluation and the new risk classification criteria, are yet to be published.

“Moreover, since the present Covid-19 outbreak, the IVDR implementation progress has come to a total halt. Already before the pandemic, the European Commission had indicated that focus on the implementation of the IVDR would only start in earnest after the MDR transition period has ended. Consequently, MedTech Europe strongly believes that the transition timeline needs to be adapted by at least 12 months, both to address today’s reality and to prevent unintended fall out in the future.”