1. November 2022
In July 2022 MedTech Europe published a Survey Report with an analysis of data from the medical devices industry gathered in April 2022. It focused on the delays in certification of general medical devices and active implantable medical devices and included a plea by MedTech Europe for a course correction to avoid the likely scenario of thousands of devices otherwise being excluded from the market.
The Medical Device Coordination Group's (MDCG) 2022-14 Position Paper (the Response) is a direct response to MedTech Europe's Survey Report, containing 19 proposals for action to provide a solution to the certification delays.
Below we discuss whether MDCG's proposed actions are likely to be much of a solution to what's likely to soon become a crisis not only for the devices industry, but also for healthcare providers in the EU, UK and around 100 other countries that rely on CE marking for medical devices.
The survey is said to represent 60-70% of the market revenues in the EU. The most concerning statistic is that for more than 85% of devices currently on the market and certified under the Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMD), certificates had not been issued at the survey date of April 2022.
Manufacturers have been able to obtain EU Medical Device Regulation (MDR) certificates for their general medical devices since BSI Netherlands was certified as a notified body (NB) in January 2019, although it was not until August of 2019 that the third NB was named (DEKRA).
Thus, theoretically and assuming the best-case scenario, the effective total time available for recertification of devices certified under the MDD or AIMD was 64 months (until 26 May 2024 when all certificates under the directives must expire).
Of that time, more than 60% had elapsed by the time the survey was undertaken (39 months of a possible 64). This assumes that all manufacturers have been able to obtain a certifying notified body - in fact 30% of SMEs have not been able to do so.
So, with 40% of the time that was available remaining, 85% of the devices are yet to be recertified - and that's without even considering new devices, up-classified devices (of which there are around 55,000) and in vitro diagnostics (IVDs).
It looks highly likely that a large proportion of devices requiring recertification will fail to achieve MDR certification before time runs out unless drastic action is taken, and soon given the final deadline of 26 May 2024.
The MedTech Europe Survey did not look at IVDs. IVDs manufacturers have been able to apply for certification under the In Vitro Diagnostic Regulation (IVDR) since October 2019 when DEKRA became the first notified body designated under the IVDR. Only seven notified bodies are currently registered in the NANDO database for certification of IVDs under the IVDR.
It is estimated that around 85% of IVDs require certification under the IVDR compared with 10% under the In Vitro Diagnostic Directive (IVDD). To add to the timing and capacity challenges that apply equally to all types of medical device, many specialist IVD companies have never had to obtain certification before, so lack experience of engaging with NBs. Thus, the delays being experienced with general medical devices are likely to be exacerbated for IVDs.
The survey identified a number of issues including the following:
If the EU Commission, the MDCG and Notified Bodies do not get to grip with the slow rate of certification of medical devices in the short term, the EU as well as the UK and the approximately 100 other countries relying on the CE mark are going to see a noticeable shortage of medical devices and IVDs in their healthcare facilities.
Manufacturers anticipate that 33% of devices will be discontinued: leading to a less competitive market and higher prices for the devices that do remain available. It is already the case that around 50% of medical device manufacturers are deprioritising the EU market and most are prioritising the US market instead, including EU-based manufacturers. This means that the EU will not be at the forefront of the deployment of innovative devices in healthcare.
Furthermore, the high burden of the regulations mean that we are likely to see SMEs exit the market altogether. SMEs frequently bring the more innovative products to market – further exacerbating the decrease in innovation. This will be felt in European healthcare systems which are already subject to energy and other price increases due to world events.
Look out for our next article that offers practical tips for how to manage this situation.
von Alison Dennis und Alice Matthews
von Alison Dennis und Nicholas Vollers
von Alison Dennis