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Euro Convergence: Looming deadlines, regulatory bottlenecks keep EU officials up at night

Posted 26 October 2020 | By Kari Oakes 

Euro Convergence: Looming deadlines, regulatory bottlenecks keep EU officials up at night

The opening plenary session of the Euro Convergence 2020 virtual meeting brought together regulatory professionals from industry, notified bodies and competent authorities. The virtual format, said co-chair  Gert Bos, FRAPS of the Netherlands’ Qserve Group, meant that it was possible to draw together a record 14 individuals for the session.
 
Co-chair Sabina Hoekstra-van den Bosch, PharmD, FRAPS, asked session participants what is keeping them up at night in 2020, especially with regard to upcoming Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) changes.
 
In answering the question posted by Hoekstra-van den Bosch, regulatory strategy principal at TUV SUD, It was unsurprising that industry representatives on the panel shared about uncertainties, fragmentation, and the sheer volume of work that faces them between now and the May 2021 MDR and May 2022 IVDR rollouts. Notified bodies also expressed concern, noting significant workforce shortages that may contribute to bottlenecks.
 
However, competent authorities themselves are worried, said the panelists representing those agencies. Armin Ritzhaupt, PhD, scientific administrator at the European Medicines agency, said it’s vital that regulators, notified bodies and industry keep “looking into ways to work better and more collaboratively together.”
 
This is especially true, he said, as regulatory paths are increasingly crossing for new drugs and products. Connected devices and combination drug-device products represent challenges when device and pharmaceutical regulatory pathways are siloed. Ritzhaupt also noted that applications for companion diagnostics and digital therapeutics – “often used in combination with medicines products” – are on the rise.
 
Waldo Weijers, PharmD, of the Netherland’s Medicines Evaluation Board (MEB) concurred, calling for “better cooperation between the drug world and the device world.” He noted that in his country, there is a near-complete separation between evaluation of drugs and devices or IVDs, with the MEB being only a drug competent authority.
 
From his perspective, concerns about the looming MDR and IVDR deadlines include the potential for unmanageable peak loads for drug competent authorities when medical devices have an ancillary drug substance. Exactly how the re-consultation process will go when crunch time comes is not clear, he said, noting that the UK’s MHRA had fulfilled the role of a drug competent authority previously.
 
Upcoming requirements and an assessment policy “still have to crystallize out” regarding the new consultation procedure for “substance-based devices,” as specified by Rule 21, and for devices that are deemed to have a “non-medical purpose.” Further, Weijers said there’s a real risk that marketing application holders of products falling under Article 117 – single integral/medicinal products – not being able to fulfill their requirements in time to meet deadlines. Not only might this hamper efforts to receive a marketing application, but in the worst case, shortages might result, he said.
 
Micha Nuebling, PhD, of the Paul-Ehrlich-Institut spoke to EU reference laboratories (EURLs), noting that there are just a small number of these laboratories, and the scope of individual laboratories can limit their utility for application holders. Laboratories are expected to receive EURL designation in the last two quarters of 2021, just a few months before the 26 May 2022 deadline. “I just have no idea how to deal with this many devices in this short a time period,” said Nuebling.
 
Panelist Eric Klasen, of Waypoint Consulting, was asked whether another MDR delay is likely. “There has been some kind of thinking developing that it’s normal to postpone regulations when there are some problems or hurdles,” said Klasen. The delay announced this spring, he said, was “an extremely exceptional measure…. Clearly I cannot see politically how it would be accepted to have another delay.”
 
Euro Convergence
 

Tags: convergence, EMA, EU

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