MedTech Europe on Wednesday newly urged the European Union to delay implementation of the In Vitro Diagnostic Regulation in response to the coronavirus crisis as well as broader concerns about the lack of preparations for the incoming rules. The call comes on the heels of EU authorities deciding to delay the go-live date for the Medical Device Regulation (MDR) by 12 months, which the trade group supported.
With the delay to MDR expected to take full legal effect soon, MedTech Europe has turned its attention back to IVDR, warning on Wednesday that “even before the COVID-19 pandemic, very little progress had been achieved” to get ready for the new regulatory system. "Well into the second half of the transition period, there are still only 2-3 Notified Bodies designated under the IVDR" and a lack of critically needed published guidance on topics such as performance evaluation and risk classification criteria.
Because the pandemic has caused progress toward IVDR implementation “to come to a total halt,” MedTech Europe said, it wants the EU to delay the regulations by at least 12 months "both to address today’s reality and to prevent unintended fall out in the future."
The long, steadily escalating effort to get MDR delayed has finally gained traction in recent weeks, with a proposal to push back the date of application by 12 months moving quickly to a positive vote in the European Parliament last week.
The European Commission issued a statement on Thursday celebrating the proposal's adoption by the Parliament and the Council. "This will allow all key players - member states, health institutions and economic operators to give priority to the fight against the ongoing coronavirus pandemic, forming a key position in the timing of the lifting of confinement measures as member states return to the road of recovery," the EC statement said. The remaining final step is for the amendment to be published in the Official Journal of the European Union.
Following last week's vote, the Council and Parliament said the revised timeline should enter into force “as a matter of urgency...in light of the overriding need to immediately address the public health crisis associated with the COVID-19 outbreak.” The delay resets the date of application for MDR to May 2021, although the retention of the 2024 end to the transition period means the industry could face a challenging compressed timeline in the future.
MedTech Europe welcomed the MDR delay. As the trade group sees it, the change will free medtech companies to focus on COVID-19 and buy the EU time to update its mutual recognition agreement with Switzerland and customs agreement with Turkey, as well as build out the new regulatory system.
The removal of the near-term threat posed by the May 2020 MDR deadline led MedTech Europe to now turn its attention to a more distant problem. Despite the delay to MDR, the comparable regulations on in vitro diagnostics are still due to take effect in May 2022.
Although the IVD industry still has two years to prepare, MedTech Europe argues the timeframe is insufficient, particularly in light of COVID-19's disruptions.
“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,” the group wrote.
That view is based on a belief that COVID-19 has stopped progress toward implementation, thereby exacerbating the fact that the EU is yet to publish guidance documents or designate more than a few notified bodies.
In a statement to make that case, MedTech Europe also argued the EU and member states erred by failing to immediately permit regionwide derogations for COVID-19 tests. The EU has created such a path to market for certain medical devices but has yet to do so for IVDs, prompting MedTech Europe to bemoan a “missed opportunity ... [to] facilitate timely and even access to the new COVID-19 tests."