Notified body pressures and registration requirements are two factors, among others, that may persuade companies not to try and make use of the derogation extension periods featured in the EU's Medical Devices and IVD Regulations.
Experts underscored these points during the first two days (June 12 and 13) of the week-long Knect365 MedTech Summit in Brussels.
In theory, the derogation extension would allow companies to maintain medical devices CE-marked under the current directives on the EU market beyond the date of full application of the Medical Device and IVD Regulations, until May 26, 2024.
Companies can, theoretically, apply to be audited against the current directives up until as close as possible to May 26, 2020, in the case of the MDR, and May 26, 2022, in case of the IVDR, allowing time for getting audited and receiving conformity assessment certificates. Firms can try to do this in such a way that they could gain up to four more years to market these products in the EU after the full date of application of the MDR and IVDR.
Many in the sector are depending on the extension derogation to lengthen the time they have available to comply with the MDR and IVDR. It could help companies that have huge numbers of products to put through the system, for example, or those that, for one reason or another, have delayed preparing for compliance with the new regulations.
This derogation is also regarded by many as the answer to the bottleneck situation that is likely to occur as companies try to be assessed by notified body against the new regulations in what is expected to be a very short period of time. Indeed, it looks as if there will be only 10 months between thefirst designations of notified bodies under the MDR and the full application of its rules.
Notified Bodies Too Busy To Audit Against Directives
While the extension may seem like an attractive option, a growing number of risks to this strategy are being identified. For one, there is a restrictive list of conditions that apply to the extension provisions. According to the MDR and the IVDR, the derogation extension can be applied except where products are covered by the regulations for the first time, and where significant design changes are planned. (Also see "Who Can Use MDR's Four-Year Derogation Extension? Notified Bodies Try To Clarify" - Medtech Insight, 21 May, 2018.)
On top of that, there will be practical barriers to applying the extension. Gert Bos,executive director and partner at Qserve group,reminded delegates that the deluge of companies applying for the renewal of certificates under the directive at the same time as those applying for certification under the new MDR and IVDR is going to put the notified bodies under immense pressure.
He estimates that less than 10% of companies have already applied to extend their certificates under the directives, but that an extension may be sought for up to 50% of products in total.
Companies considering making use of the derogation extension need to be aware that the huge demand for notified body services will mean that these bodies may set their own arbitrary deadlines for testing products against the current directives, because they will need to turn their attention to auditing products against the new regulations.
He even suggested that by the end of this year, notified bodies are unlikely to be accepting applications for early renewal under the directives, as they will have to prepare for work under the MDR.
He advised companies to be careful with timing. Firms that wait too long to make use of the extension derogation may find themselves unable to do so. As a result, a company could be forced to either rush toward compliance with the new regulations, or to withdraw products from the market.
The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices andinvitrodiagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials...
His words were echoed by Bassil Akra, VP of global focus teams (cardiovascular, orthopaedic and clinical) atTÜV-SÜD Product Service (Germany). He urged companies not to delay in making decisions and to ensure now that their notified body has the capacity to address their determined way forward.
Both experts drove the message home vehemently that there is no time to waste to prepare for compliance under the new regulations.
The message, also supported at the meeting by Hans Heiner Junker, senior international affairs manager atTÜV-SÜD Product Service, was that despite the lack of detail available about how to implement the new requirements, companies need to get a move on now, even if it means having to shift paths later when new information is available.
Registration Requirements May Tip Balance
Attendees also heard how industry needs to factor in the costs and logistics – details of which are still scant – of having to address registration requirements for products that continue to be CE-marked under the directives during the extension period.
There are likely to be significant demands to addressing these registration requirements that will apply to any company wanting to comply in full with the MDR.
According to the Medical Device Regulation, where CE marking is extended into the derogation period, the requirements of the MDR "relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
This is especially the case, given uncertainties related to the timing of getting the new Eudamed medical device database up and running. Eudamed is where the registration information ultimately must be inputted. There are also Unique Device Identification requirements to consider for inputting information into the Eudamed database.
It is not specifically mentioned in the MDR/IVD texts that legacy products will be subject to UDI requirements beyond assignment of a "Basic UDI-DI," which are not linked to the full suite of product attributes that must be associated with a "UDI-DI" under the EU system. But it remains to be seen how the necessary information could be inputted with these requirements.
This could lead to an additional onerous job for companies that might have thought they were taking an easier option by applying to extend their certificates under the directives for an additional four years.
Such additional challenges must be balanced by companies when determining strategies; they could potentially drive firms to engage in portfolio rationalization exercises. Also, the benefits and risks linked to these additional requirements for legacy devices need to be carefully weighed, as it will add to the complexities in the development of the Eudamed database, according to Celine Bourguignon, head of QRA & Clinical at Cardinal Health.
One delegate also pointed out that companies claiming compliance with the directives for legacy products would need still need to upload periodic safety reports to Eudamed starting on May 26, 2021, as required by the MDR.
From the editors of Clinica