At the end of last week, the Competent Authorities for Medical Devices (CAMD) released a statement following their 50th plenary meeting. The statement discusses the ongoing transition to the Medical Device Regulation (MDR) and the widely reported urgent capacity challenges facing the medical devices industry. For more detail on the effects of conformity assessment delays and Notified Body (NB) shortages, please see our article here.
The CAMD recognises the risk of disruption to the supply of essential medical devices, and that patients’ access to medical devices may be affected. The CAMD is also aware of the chilling effect this may have on innovation. By working together with the European Commission and the Medical Devices Coordination Group (MDCG), the CAMD plans to ‘urgently seek and consider all potential solutions’. Further, the CAMD notes the necessity of close collaboration with NBs.
However, while these statements are somewhat encouraging, the CAMD then takes a tough line on any “flexibilities”. The CAMD:
- strongly resists any relaxation of the MDR requirements or further delays or deferrals; and
- emphasises that the various derogations in the MDR (whether for legacy MDD devices or new MDR devices) must be the exception and not the rule.
The CAMD is of the view that derogations under Articles 59 must be limited to specific requests and only be granted when in the interests of public health, patient safety or patients health. Economic considerations must not be taken into account. The drafting is a little unclear as to whether this drafting also applies to Article 97.
This suggests that the pleas for assistance have fallen on deaf ears and there well may be trouble in store for the entire MedTech sector.
Yesterday, the CAMD statement was followed by an MDCG position paper masquerading as guidance.
This discusses the rollout of the new regulatory framework. The MDCG takes a similarly tough line and criticises manufacturers for not being suitably prepared. The MDCG adds some specific guidance in relation to Article 97. In essence, Article 97 derogations will only be available where the Manufacturer has undertaken all reasonable efforts to conclude its MDR transition, including updating its new QMS. The Manufacturer must have submitted an application to a NB for certification in compliance with the MDR at least one year before the expiry date of the MDD/AIMDD certificate. For the majority of devices, which have a May 2024 expiry date, the new dossier and the new QMS must be complete by May 2023.
Neither of the notes specifically addresses the application of derogations to a legacy MDD device where the manufacturer does not intend to transition to MDR.
These two documents, although neither is guidance, suggest manufacturers are expected to carry the burden of the inadequate infrastructure. Manufacturers that fail to submit complete applications in time will seemingly not be met with much sympathy.
We summarise the position as follows:
|Question||Answer – MDCG & the CAMD Statement|
|Will the May 2024 deadline be extended?
What about the May 2025 deadline to remove legacy devices from the supply chain?
Not mentioned, but unlikely
|Will there be any broad automatic “relaxations” or regulatory “flexibilities”?||No|
|Will NCAs grant broad derogations under Article 59?
This would allow devices to be PotM within that MS where a Conformity Assessment has not been undertaken if this is in the interests of public health etc?
Derogations should be specific and only in cases of public health etc and not for commercial considerations.
|What about derogations under Article 97 for (“formally non-compliant” devices that are otherwise assessed by the NCA not to present an unacceptable risk)?||This derogation should only be applicable where the Manufacturer has submitted an application to a NB for certification in compliance with the MDR (and finalised its new QMS) at least one year before the expiry date of the MDD/AIMDD certificate.|
Catch up on the Spotlight on IVDR series below, where we analysed the challenges posed by the IVDR and how regulators might respond to them:
- Spotlight on IVDR – Cheers Slovakia! Seventh Notified Body designated under IVDR
- Spotlight on IVDR – Why we keep banging on about Notified Bodies
- Spotlight on IVDR – Circumventing the Notified Body bottleneck
- Spotlight on IVDR – Will the European Commission blink?
- Spotlight on IVDR – The European Union’s new In Vitro Diagnostic Medical Device Regulation is here