We understand[1] that TÜV SÜD has just been approved as the second Notified Body capable of certifying against the incoming EU Medical Device Regulation[2] (EU MDR).[3] With the demand for Notified Bodies set to increase dramatically, this is a welcome development. In isolation, however, it is unlikely to be enough to prevent a considerable approval bottleneck for medical devices, and all the problems that entails.

The EU MDR

From 26 May 2020, the EU MDR will be in full effect, representing a significant overhaul of the medical devices regulatory regime, previously set out in the Medical Devices Directive[4] (MDD). The MDR aims to increase the obligations and scrutiny on manufacturers, as well as other players in the medical devices field, in response to various scandals in the industry.

To that end, the EU MDR is set to introduce a range of high profile changes, which include, but are not limited to:

• An increase in post-market surveillance obligations;
• The introduction of a Person Responsible for Regulatory Compliance;
• The introduction of EUDAMED, an EU-wide database which must contain data on each medical device placed on the market in the EU; and
• A change in classification for a number of classes of device, meaning significantly more devices will fall under the MDR and/or will require approval by a Notified Body for the first time (including software medical devices).

The Notified Body bottleneck

Causing the most concern to industry is the last of these points. Firstly, there is no ‘grandfathering’ under the EU MDR. This means that medical devices in class IIa or above, currently approved under the MDD, will need to be reapproved under the EU MDR.[5] Added to this, many devices have moved to a higher classification under the EU MDR, some of which will require certification for the first time. These will dramatically increase the demand for Notified Bodies.

Compounding this pressure is the fact that, until this week, only one Notified Body had been approved for certification under the EU MDR (BSI UK). The medical devices industry (and regulators) are, understandably, highly concerned about the implications of this.  At the end of last year, MedTech Europe released a position paper noting the knock-on consequences of a lack of certified Notified Bodies for patients.[6] Shortly after, ANSM (the French Competent Authority) released minutes of a public meeting[7] stating that a majority of Competent Authorities would support a new ‘grace period’ being introduced for products requiring Notified Body certification for the first time. ANSM noted that the Commission was preparing a corrigendum to the EU MDR to reflect this. At the time of writing, however, no such change had been announced.[8]

TÜV SÜD’s approval – is it enough?

While the approval of TÜV SÜD as the second EU MDR Notified Body is certainly a step in the right direction, it is unlikely that this alone will be enough to prevent a serious approval bottleneck and to assuage the concerns of industry and regulators. The extent of the issue is perhaps best highlighted by the fact that there were roughly 50 Notified Bodies capable of certifying against the MDD, while even with the approval of TÜV SÜD, there are currently only two for the EU MDR. It is worth noting that another 40 or so applications for approval have been made by Notified Bodies, but at this stage it is unclear if, and when, these will be approved, particularly as we understand TÜV SÜD’s initial application was made some time ago. Meanwhile, May 2020 moves ever closer.

There is also, of course, the spectre of a possible no-deal Brexit, which could render BSI UK incapable of certifying products for the EU market in any event[9], which (in the absence of any further Notified Body approvals) would bring the total of available EU MDR Notified Bodies for the EU Market down to merely one.

As such, while the approval of TÜV SÜD is undoubtedly a step in the right direction, it is unlikely to be sufficient to ward off what a senior executive there recently described as the EU MDR “horror story”[10]. It is unclear what steps (if any) the Commission is taking to address these concerns, but it is clear that there is a real risk of fewer medical devices on the market in the near future, which would ultimately have an impact on patients.