Transitioning to the EU’s medical device and in vitro
diagnostic regulations (MDR/IVDR) have left industry with no choice but to resort to contingency planning, including an IVDR “plan B.”
From the looming shortfall of notified bodies (NBs) to the ongoing lack of MDR/IVDR guidance, 2019 FDA/Xavier MedCon conference sessions underscored daunting realities related to the regulatory overhaul. NBs, manufacturers and regulatory authorities have come increasingly under pressure to mitigate the impact of the transitions, which are so far shaping out to be worse than experts could have anticipated. But at least one outcome has become more and more clear since 2017—some EU firms will not survive.
“It’s a horror story,” according to TÜV SÜD Product Service GmbH VP Bassil Akra’s characterization of MDR. “Some manufacturers will not survive. This is very clear. They will not be on the market anymore.”
This year’s conference sessions demonstrated that the situation has largely remained the same since 2017, eliciting some murmurs in the crowd and a few nervous chuckles. Most industry participants have tried to inch toward preparedness despite the hurdles.
Gert Bos, executive director and partner at Qserve consultancy, pointed to many of the current unknowns that continue to hinder appropriate preparations. These relate to the most significantly impacted areas in the current landscape, such as postmarket surveillance and unique device identification, and the body of new guidance needed to ensure consistent approaches. Yet Bos confirmed in an interview with Focus
that industry made some progress versus 2018. Most industry participants are now actively implementing MDR and/or IVDR or completing initial gap assessments.
The progress that Bos’ poll demonstrated came as a welcome surprise. Bos told Focus
industry was left with no other option but to create certain workarounds to sidestep the lack of progress on the part of regulatory authorities. Small- to medium-sized companies developed templates for their shared interpretations of what can be done and be “good enough,” while larger firms hosted “belief sessions” to help their staff move past being stuck on certain issues like budgets, Bos said.
A benefit awaiting those who successfully transition is job security because regulatory compliance in the future system will be a moving target requiring ongoing and continuous discussions, Akra said.
Yet another type of transition emerged in reaction to that of MDR/IVDR—a cultural shift spanning within and across the EU’s medical device ecosystem. This shift is expected to be a future benefit as well. With the European Commission’s (EC) unwavering commitment to apply MDR/IVDR by May 2020/2022, others have followed the way of mitigation to avoid unintended consequences.
Notified Body Challenges
Bos, Akra and Medcert managing director Klaus-Dieter Ziel urged industry to consider what has remained a major concern across the board. There will not be enough NBs designated against MDR or IVDR in time to meet the increased demand, they argued. Akra further noted that even when NBs are designated according to the new regulation, they are unlikely to start accepting applications or resubmissions before summer. A shortfall in product availability will be inevitable in the event of such delays in (re)certification processes.
NBs have upped their staffing efforts and looked to additional resources in preparation of the greater workloads that await. A sole NB—BSI UK—has been designated
against MDR so far and none against IVDR. But the EC has had discussions behind closed doors for an IVDR “plan B” just in case, according to Akra. The alternative to designating the necessary number of NBs would allow regulatory authorities, such as the European Medicines Agency (EMA), to step in and act as NBs. This would be like the US Food and Drug Administration’s (FDA) use of third-party assessments on 510(k) submissions, Akra told Focus
NSF International executive director Robyn Meurant pointed to the “dire situation for devices” in arguing that it is “perhaps worse” and “even more dire” for IVDs in terms of NBs under IVDR. Only seven NBs applied for IVDR and the percentage of new IVDs that will require an NB will be 80%—up from 10%.
Bos explained to Focus
that there are other challenges too: One relates to the clause in the legislation that forbids NBs from starting any work in their anticipation of achieving designation, which in turn blocked any chance NBs had to roll out certificates on anything reviewed and audited prior to the dates of application. “If that little sentence had not been there, we could all trust NBs to get there ultimately at least among those that are ahead of the curve,” he said.
Another challenge with IVDR designation is the MDR process being a prerequisite and joint assessment teams contradicting what their colleagues already accepted, noted Akra. The designation process is also lengthy, with Ziel noting that Medcert’s recent joint assessment lasted more than 200 hours of auditing.
In addition to the lack of IVDR-designated NBs, a recent EMA guidance
only targeted an article under MDR. Bos touted FDA’s Center for Devices and Radiological Health for issuing large numbers of guidance documents to aid industry with compliance as well as for keeping its doors and phone lines open for industry, calling for this to be the case in the EU as well. Akra clarified the EC intends to allow manufacturers’ reliance on mutual agreements or common understandings among NBs in lieu of regulators’ guidance.
The UK’s Medicines and Health care Products Agency (MHRA), meanwhile, has issued a string of Brexit no-deal guidance documents over the past several months. The culture shift away from centralized operations toward greater use of third-party auditing bodies is also taking place behind the scenes at MHRA, Bos told Focus
. MHRA’s director of devices recently reported
his plans to step down at the end of October, coinciding with the new Brexit date. Bos is hopeful UK MDR
will serve John Wilkinson’s legacy as the UK’s version is closely aligned with EU MDR and MHRA guidances provide needed flexibility.
But those that have a presence in the UK market are expected to be most heavily impacted since the post-Brexit scenario adds to the uncertainty. Device firms should try to mitigate the Brexit risk through internal discussions and discussions with NBs about whether the risk is worth it, Akra said.
Bos also cautioned early engagement with NBs will be crucial moving forward. This is because NBs are not currently taking phone calls, but are more likely to prioritize long-standing customers with devices like implants than new clients with lower risk devices.
“Help us by sharing with us evidence that is reasonable and do not try to go down a road that does not make sense because you will get stuck and not continue down the road to certification,” Akra said. He recommended scaling back on existing product portfolios and keeping an eye out for corrigenda the EC will issue in upcoming months to codify the regulation. The first corrigenda was released