Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?
By Amanda Maxwell, European Regulatory Affairs Editor, Medtech Insight
Medtech companies need to do an in-depth check that their notified bodies will be able to still service them under the new EU Medical Device Regulation, Bassil Akra advised delegates at the Medtech Summit in October organized by Informa Connect. Akra is CEO and co-owner of Qunique consultancy.
Do not expect, because you have been working with a notified body for many years, that it will get the same designation scope under the MDR as under the Medical Devices Directive (MDD), warned.
Akra was chairing a session entitled Notified Body Panel Discussion: EU MDR Pain Points, the most popular session at the virtual meeting. Topics covered included potential auditing bottlenecks, capacity and staffing, what notified bodies see as the biggest challenge for manufacturers in submitting their applications for conformity assessment and alignment in notified body operations.
One of the familiar pain points is that far too few notified bodies has been designated under the MDR and that the result is predicted to be bottlenecks as manufacturers scrabble to meet the 26 May 2021 date of full application.
There are currently 17 notified bodies designated under the MDR and 54 under the MDD, which has been the regulatory vehicle for the medical device industry since the early 1990s.
When asked whether she was optimistic that as many as 45 notified bodies could be designated by next May, Elaine Darcy, European medical device operations manager at Irish notified body NSAI, said she did not think this was realistic. She reminded the audience that progress to date has not been so promising: some 11 notified bodies had been designated at the end of 2019 despite the European Commission having promised 20 by that date.
Moreover, Darcy said, the COVID-19 pandemic is hampering the efforts of the designating authorities in performing joint assessment audits of those notified bodies that have not yet reached this stage. She added that a few notified bodies who are quite advanced in the designation process are still likely to be designated by the year end, or before the date of application, but that the industry should not expect a sudden rush of designations.
Bart Mersseman, certification and business enhancement, global medical devices certification manager at SGS Belgium notified body, added that his organizations designation has been delayed by the pandemic and social distancing, although moves to get the organization designated soon are underway again.
It is not just the overall numbers of notified bodies and their designation scope that manufacturers need to research carefully, but also whether a notified body has capacity to take a new application for new devices under the MDR, for example, the meeting heard.
When asked if his notified body would take on new MDR applicants, Martin Witte, global director active implantable and cardiovascular devices at TÜV SÜD Product Service, said during the panel session that the general answer at his notified body is yes.
But in terms of timing, there might be challenges, he said; the full response will depend on areas of designation, and whether the current resources are free to do the required auditing and technical documentation review in that product area, he explained.
The issue is that it is not so just how many notified bodies have been designated, but also the specific product scopes for which they have been designated overall. For example, if there are only three notified bodies available and they have just a few of their auditors working on certain special codes, then the on-boarding of clients in these areas might be delayed, Witte said.
Notified bodies have been working to try and manage this over the last couple of years through hiring the necessary personnel.
But this has been a challenge, as companies are aware too, because it is difficult to find sufficiently qualified personnel. “I think this will create a bottleneck situation for the future,” Witte said. But in general, yes, notified bodies accept new applications, he said.
Indeed, a recurring theme during the MedTech Summit and generally during the October virtual medtech regulatory meeting bonanza was how difficult it is for notified bodies to predict the product-specific expertise that they are going to need to match it to demand, especially when it comes to new products being audited for the first time.
There are also companies having to unexpectedly transfer from other notified bodies, as well as other unanticipated challenges, which will add the unpredictability of demand industry is hearing. Indeed, an element of hiring key staff is guesswork and could result in shortages in availability of staff in given areas and staff needing to be retrained in different areas, a lengthy and resource-consuming task.
Akra warned that the notified body issues will mean that manufacturers with innovative devices could well find that they are facing a long queue for conformity assessment because capacity is limited, and the number of requests is higher than available capacity. “We are going to have delays getting products on the market, especially when we are talking about new products entering the for the first time,” he predicted.
Turning his attention next to manufacturer preparedness, Akra asked what kind of issues cause the biggest challenge for manufacturers in terms of clinical details in their technical documentation.
Yvonne Ndefo, chief clinical evaluator at NSAI, said her organization has already started reviewing MDR files. The most frequent questions we see from a clinical perspective relate to the clinical evidence report (CER) and the quality of the clinical evidence provided, she explained.
Many manufacturers also seem unclear over post-market clinical follow-up (PMCF) requirements under the MDR, she added. There is a false notion among some manufacturers, especially of class III devices who do not already have an MDD certification, that they will not need a PMCF plan and report under the MDR.
Going forward, Ndefo explained, “we need to see a PMCF plan and report and the CER needs to be more robust under the MDR.” She noted that questions are particularly likely to come up where there is a new specific requirement related to the CER report which differs from what is needed under the MDD. This includes, for instance, additional information needed in the clinical development plan where, under the MDR, the manufacturer must include details of the whole process from first in man and to clinical trials.
The increased clarity and better definition of these requirements under the MDR is what challenges manufacturers, Akra, agreed, since they bring higher expectations of the kind of clinical data would be needed for different kinds of devices, he said.
Turning then to Jayanth Katta, senior regulatory lead at BSI Regulatory Service, Akra asked what his experiences are with MDR technical documentation. “Do you have any major issues that happening consistently or is it different from one manufacturer to another?” he asked.
At BSI, Katta said, “we are seeing consistent gaps in certain areas in clinical evaluation. As Yvonne [Ndefo] said, clinical evaluation is the first one where we see the most gaps.”
The second common area is quite surprising, he said. It relates to manufacturers not being able to present clear design iterations on the design history of the device and how the various tests and evidence they have generated relates to the final iteration of the device.
It is to do with design verifications and validations and how manufacturers are meeting some of the GPSRs. The reasons for the gaps is that the technical documentation frequently fails to clearly explain the various iterations of the device that have happened over the years and how the evidence that has been generated over the years might now relate to the final iteration of the device.
If you look at Annex II of the MDR, Katta said, it says that manufacturers must include the design history in their technical documentation. It’s really important to make it clear to the notified body which is the final version of the device that you are applying for under the MDR, he added. If the product has previously been assessed under the directives, and there have been any changes to the device between how it was approved under the directives ), and now how you are applying for it under the MDR, it is vital to make these clear. This is because those design changes may mean that a clinical evaluation consultation procedure is then necessary (where an expert panel needs to review the notified body’s assessment of the clinical data).
Notified body assessors are going to get lost in the documentation trying to figure out what it is they are trying to review if the evidence has been generated over the last 15 years and changes in materials and design are not simply puts together without presenting a clear story, Katta explained.
The third area Katta cited where notified bodies are seeing problems is challenges with software, “because of the many new requirements. There is a specific rule related to independent software devices and we are seeing quite a few questions there.”
Akra added that there is a tendency for manufacturers to follow the old legislation with regard to technical documentation expectations and understanding because some MDR requirements are not clear enough yet in the guidances. This is causing confusion for notified bodies too. The missing guidances are leading to “a lot of personal interpretation” and to piecemeal adoption to be able to keep the system working, said Akra.
Medtech Insight notes that technical documentation is also a key concern for IVD notified bodies. Andreas Stange, vice-president medical and health services at TÜV SÜD told Medtech Insight last month, following news of it issuing its first IVD Regulation certificate, that “if this is poor, corrective action by the manufacturer can take quite some time.” He added, “The quality of the technical documentation is key.” MT142982
In response to the questions of how notified bodies ensure alignment throughout their organizations, SGS Belgium’s Mersseman said that SGS managed through training and providing information to auditors. The SGS senior witness other auditors from time to time. This procedure is also assessed by European Commission’s joint assessment team during the designation phase to ensure that notified bodies have procedures in place to synchronize internally.
Daniele Bollati, medical devices lead auditor and laboratory expert at IMQ suggested that some manufacturers may not be aware that certification time now takes longer because of checks on findings by line managers before the conformity assessment certificate is issued. Akra noted that notified bodies are doing their best to ensure alignment. “But 100% alignment cannot be guaranteed,” he said.
He summarized that notified bodies are doing their best effort to ensure alignment “but 100% harmonization cannot be achieved because notified bodies will need to consider local expectations.” Their member states pushing them in a direction which comes on top of the legal obligations that come from the regulations, Akra said.
So, we may still see in the industry some differences which are related to the member state in which each notified body is based, and some differences related to the fact that notified bodies are still in the learning process, learning how the regulations – published three years ago – are intended to operate. Even today after decades of the medical device directives applying, notified bodies are still discussing and exchanging about the MDD expectations because the interpretations change day by day.
Akra finished on a positive note, saying that there are a lot of combined efforts, from industry, and notified bodies and competent authorities to work towards harmonization.
