Notified body (NB) availability and readiness for implementation of the EU’s medical device and in vitro
diagnostic regulations (MDR/IVDR) stand out among “burning points” in need of authorities’ attention, according to industry group MedTech Europe.
The group’s director of regulations and industrial policy, Oliver Bisazza, explained how time is running out on MDR/IVDR implementation, and not just because of the 2020/2022 deadlines, but also due to lack of progress and preparations.
The biggest issue facing industry as it relates to MDR/IVDR implementation is the “timely readiness of the new regulatory system,” said Bisazza, citing the incomplete work on implementing acts, guidance documents, expert panels, EU reference laboratories, high-risk IVDs’ common specifications and NBs.
A number of pending MDR/IVDR essential implementing acts
and guidance documents were highlighted. The first in a series of forthcoming guidances from the European Medicines Agency (EMA) was issued
late February. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also issued its own guidance
to aid in compliance with MDR and IVDR under a no-deal Brexit scenario.
The UK’s guidance and legislation are also in need of updates to reflect the new Brexit date—12 April. Although Prime Minister Theresa May said Tuesday she’s pushing for a further extension.
The EU’s the Medical Device Coordination Group (MDCG), established by the regulations in 2017, has endorsed guidance documents covering certain topics, including unique device identification and the content of new products certificates, among others. The European Commission (EC) also endorsed
MDCG’s document on the EU’s nomenclature last month.
The EC has not set up the expert panels for MDR’s premarket clinical evaluation consultation procedures, with MDCG recently urging
clarification of these provisions. There are no EU reference laboratories and class D IVDs common specifications either, despite being essential implementing acts.
For MedTech Europe, however, the most pressing issue is NBs’ early availability and capacity. The sole NB officially designated
against MDR—BSI UK—was notified by MHRA in January. There have yet to be any NBs designated against IVDR. IVDR comes into effect on 26 May 2022 versus MDR’s date of 26 May 2020, but experts caution against underestimating how close these transitional deadlines really are.
“To transition smoothly, industry needs sufficient lead-time between readiness of the system and the final deadlines,” Bisazza reported. “Most urgently, sufficient NB availability capacity must exist many months before the dates of application.” Patient care and safety, product supply to hospitals and laboratories, innovation and small- to medium-sized enterprises are his examples of what is at stake.
MedTech Europe’s requests to the heads of medicines agencies responsible for medical technologies include investing resources to develop in-house expertise and retaining the Competent Authorities for Medical Devices (CAMD) network post-Brexit, among others. But intervening if NBs are not available early should take priority, according to Bisazza.
NBs’ timely availability and capacity is needed due to their role in (re-)certifying up to hundreds of thousands of medical technologies. More than 85% of IVDs are expected to need NB oversight for the first time under IVDR, representing an 8% workload increase.
MedTech Europe and COCIR, meanwhile, sent
letters last month urging the EC and national competent authorities to adopt no-deal Brexit transition periods for medical devices in the interest of public health.
“Contingencies for Brexit are already long overdue,” Bisazza noted. “Contingencies for IVDR/MDR are also very nearly overdue. It seems clear that the scope and complexity of the regulations far outstrips the capacity and resources of the member states and the European Commission.”
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe