EU Notified Body Medtech Services and How to Overcome the Urgent Shortage – published 25 April 2022.
Three well-known notified body experts discuss how they are trying to make the new regulatory framework work as demand for EU notified body Medtech services rapidly outpaces capacity. Last week, Amanda Maxwell from Medtech Insight published an article in which the 3 experts address the issues.
Table of contents
- Notified Bodies in the Spotlight
- Three Experts Give Their Views
- Recruitment And Logistics
- IVD Regulation
- Added IVDR Challenges
- 2026 And 2027 Squeeze
- Remote And Hybrid Audits
- MDCG Documents
- EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: Sources, Links and Downloads
Notified Bodies in the Spotlight
As manufacturers struggle to comply with the new Medical Device and IVD Regulations on time, notified bodies are continuously in the spotlight. When it comes to implementation, they are the cornerstones. As the pressures mount and they must adjust to the extra work that new structures and documents entail, these critical structures are bearing the burden of handling the missing components of the new medtech regulatory framework.
Three Experts Give Their Views
Representatives from three EU notified bodies described how MDR and IVDR will fail to perform as intended unless notified bodies have the competence and instruments to carry out their responsibilities. They outlined what the European Commission and other regulators must do to assist them in better performing their critical jobs.Because of the high demand for their services, each notified body must carefully consider whether it can accept each MDR/IVDR conformity assessment request.
The Expert From BSI
Manufacturers with existing BSI certificates for the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive are given priority by BSI (AIMDD), According to Medtech Insight, Graeme Tunbridge, now senior vice president of global regulatory and quality, medical devices at BSI, In other cases, he said, BSI may have to make “the difficult decision” not to take on new manufacturers until it is certain it has enough resources.
He forecasted that as demand develops over the next two years, the situation will get more difficult, particularly for the assessment of legacy devices that are still on the market and certified against applicable medical devices regulations.
Tunbridge, who was the former head of devices at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and was instrumental in shaping the new EU regulations during his time there, added that BSI is working with clients to ensure that MDR applications are submitted as soon as possible, because “timely submission of documentation is a critical aspect of ensuring as smooth a transition as possible.”
The Expert From TüvSüd
TÜV SÜD is also approaching capacity constraints, according to Andreas Stange, VP of the medical and health services group at the German recognized organization. For the time being, if his notified body is unable to accept applications immediately, he stated, he will work with manufacturers to establish a submission timetable based on the availability of specialists and the area.
So that’s the current position. However, the German notified body anticipates a severe lack of evaluation capacity beginning next year because the rate of MDD certifications being replaced with MDR certificates is still much too low. This is true for all product categories, according to Stange. Like BSI, the German notified body is pushing all manufacturers to organize their submissions ahead of time “so it can complete the transition in time and avoid any unforeseen surprises” he said.
The Expert From IMQ
Meanwhile, Daniele Bollati, medical devices lead auditor and laboratory specialist for Italy’s IMQ, noted that his notified body, as a medium-sized participant, has capacity but is taking longer to perform the tasks.
“We are aware that we can’t guarantee our [existing] MDD customers that they will be all certified under the MDR in time; it is currently not feasible in terms of man-hours required,” he said. IMQ is trying to increase, or reallocate, resources to manage the workflow.
Recruitment And Logistics
Despite considerable expenditure over at least half a decade, all three notified bodies continue to seek for new talent due to the high level of demand.
TüvSüd today has around 800 medtech professionals, with the company growing at a pace of about 20% per year over the last four to five years. In a similar time frame, BSI has nearly quadrupled its technological and clinical resources.
Unfortunately, due to the large additional requirements of the new regulations and other restraints, like as the impact of the COVID-19 epidemic, this does not equate to a fivefold increase in capacity, according to Tunbridge.
Despite this, BSI has been able to add new manufacturers as a result of its expansion.
The Importance of Good Recruitment Strategies
All three notified bodies are aiming to hire more people and are aware of the importance of good recruitment strategies, but Stange and Tunbridge both mentioned the limited talent pool that everyone participating in the regulatory system is hoping to tap into. There is also, of course, a large amount of time spent training staff to be competent in conformity assessment work.
Personnel concerns, according to Bollati, are one of the most important issues confronting notified bodies right now. In his opinion, a change of the NBOG 2017-2 guidance paper regarding qualification standards, particularly for the clinical section, would be beneficial. Bollati also feels that shortening the on-site audit length for the first certification operations (particularly for legacy equipment) could free up more notified body time.
Shortage of Auditors
Bollati’s concern about a shortage of auditors was mirrored by Stange, who claimed that a condensed program of two years of professional experience in each product area should be adequate to qualify.However, he was quick to point out that even this would not be enough to handle the workload of notified bodies in 2023/24, despite the fact that it would certainly help IMQ make better use of its existing resources, as would hybrid audits and a more consistent interpretation of Medical Device Coordination Group (MDCG) documents, he said.
All three notified bodies are concerned about the slow pace of notified body designations under the IVDR, arguing that this creates additional work for those notified bodies that have already been designated and jeopardizes some companies’ ability to transition from the Directive to the Regulation on time.Under the IVDR, both BSI and TÜV SÜD are recognized. According to Bollati, IMQ was not previously classified under the IVDD but is in the process of being designated under the IVDR.
‘Steep Learning Curve Ahead’
Experts expressed relief that the IVDR has extended the deadlines for many legacy devices. However, Tunbridge pointed out that when manufacturers begin to grasp the level of technical, clinical, and performance information that will be necessary to satisfy notified body evaluations, “a particularly steep learning curve” ahead. Nevertheless, he is hopeful that the revised IVDR deadlines will allow BSI to hire new IVD makers following the IVDR application deadline in late May.
Large Notified Bodies’ Assistance for Smaller Bodies
With the IVDR, both BSI and TüvSüD are assisting other recognized entities. TüvSüD is supporting other notified organizations in their preparation for designation by giving training, contributing to position papers, and making recommendations to the commission on how to improve the regulatory framework. Furthermore, BSI is investigating how larger notified bodies with more experience in this area might assist smaller or new notified bodies.
However, Tunbridge reiterated that there is “no quick fix.”
Added IVDR Challenges
Because so many manufacturers would be engaging with notified organizations for the first time, the outlook for conformity assessment timescales under the IVDR is more uncertain than the MDR, according to Tunbridge.
In the IVD space, Stange expressed “special concern” over the sluggish adoption of essential guidance documents, implementing rules, and standard specifications. According to Tunbridge, the appointment of EU reference laboratories is also taking a long time, and the delays will have an influence on the supply of the highest-risk IVDs.
“All this contributes to an increased IVDR workload for notified bodies and further reduces the limited assessment capacity,” Stange warned.
2026 And 2027 Squeeze
The new transition periods, according to Stange, will provide much-needed relief and help to spread the assessment burden over the coming years; however, the significant decrease in IVDR notified body applications is likely to result in serious capacity issues for designated IVDR notified bodies when the transition periods end in 2026 and 2027.
Figures from MedTech Europe indicate that for about 70% of all devices on the market, i.e., class C and B devices, the transition will fall in this period, he added. Moreover, when it comes to class D high-risk devices, Stange said, “we anticipate that the EU reference laboratories will not cover the full range of these devices so we will need to implement our own approach to batch verification for some device types.”
These are difficult challenges, he concluded.
Remote And Hybrid Audits
Remote audits are one option that could assist speed up auditing under the new requirements by reducing travel time for notified entities and complicating scheduling.
However, because the future legal status of virtual and hybrid audits (which combine in-person and remote auditing) is unknown, BSI is returning to in-person audits wherever possible (although on a case-by-case basis as restrictions remain in some countries).
‘Boots on the Ground’
For many aspects of auditing, there is “no substitute for getting boots on the ground and visiting a manufacturer in-person,” Tunbridge acknowledged. But he emphasized that BSI’s experience shows that it is possible to combine in-person auditing with simultaneous remote auditing for certain processes. This is particularly the case for practices that are non-physical in nature and mainly documentation based, such as quality management system records, he said.
“Not only is this a more efficient use of resources, but it also allows us to draw on a wider range of expertise to support the audit. It also supports one of the tenets of new legislation in increasing transparency as it means that a regulatory authority can easily witness an audit undertaken anywhere in the world,” he said.
With notified bodies’ resources stretched and more expertise in remote auditing gained during the pandemic, Tunbridge believes hybrid auditing has the “greatest potential moving forward.”
Bollati shared this sentiment, saying that notified bodies are asking the commission for a rule modification to allow hybrid audits on a larger scale in the context of the new legislation, not least because of the environmental and resource-saving benefits they provide.
While TüvSüD has returned to in-person audits conducted by its local specialists, the pandemic has made it more difficult to hire experts from other countries.
TüvSüD prefers hybrid audits, in which an on-site team is aided by a remote specialist, he said. This has shown to be highly effective in our experience. According to Stange, fully remote audits are becoming increasingly unusual.
He, too, agreed that “existing legal restrictions make them complicated and only viable in unusual instances.” Above all, Stange wants “a standard and consistent strategy across the EU allowing notified entities to perform hybrid audits.” According to Stange, who is located in Japan, travel within China is challenging, and organizing audits is tough owing to the frequently shifting pandemic situation.
Tunbridge is also concerned about keeping BSI’s teams up to date with the European Commission’s MDCG’s tens of thousands of pages of guidance. While clarity on the member states and the commission’s goals is welcome, he believes there is a risk of overburdening those who must execute the recommendations.
As deadlines approach, working on the critical concerns that will support patient access to high-quality, safe products becomes increasingly crucial, he said.
The main problem, according to Stange, is the inconsistent interpretation of MDCG advice materials by responsible authorities, which leads to time-consuming conversations with firms concerning their implementation. He’d want to see a unified approach to setting realistic implementation timelines for these guideline materials.
EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: Sources, Links and Downloads
- “Against The Odds: Notified Bodies Pinpoint The Real Obstacles And Ways To Move Past Them“ by Amanda Maxwell from Medtech Insight
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