The European Notified Bodies (NBs) have published a new position paper to address the concerns of MDR/IVDR designated NBs. It will be effective from May 26, 2022 to May 26, 2024. The MDR/IVDR regulations aim to improve patient safety by strengthening the requirements for manufacturers and NBs.
The European Association of Medical Devices for Notified Bodies (Team NB) is concerned about medical devices/IVDs shortage and the expiring Active Implantable Medical Devices Directive (AIMDD)/ Medical Devices Directive (MDD)/In-Vitro Diagnostic Medical Devices Directive (IVDD) certificates in 2023 and 2024. Therefore, Team NB presented the major concerns and proposed solutions to ensure the availability of medical devices for the European population. Let’s decode them.
Expiring AIMDD/MDD/IVDD Certificates and NBs Capacity
Regarding the pandemic, the NBs are facing challenging situations as the Directives certificates reach their expiry dates in 2023 and 2024. As per the latest polls performed by Team NB and the European Commission (EC), most of the valid AIMDD/MDD/IVDD certificates are expiring in the first five months of 2024. Specifically, it should be noted that the MDR postponement resulted in the extension of MDD certificates and a delay in the MDR submissions. Furthermore, Team NB illustrates the following challenges, where only:
- 25 NBs are currently designated for the MDR
- 6 NBs for the IVDR
- 51 for the MDD and
- 21 for the AIMDD/IVDD
Therefore, Team NB proposes the following solutions to address the challenges:
- Considering the limited grace period, a further extension of the IVDR transition period beyond May 26, 2024, should be examined (e.g., until May 26, 2025).
- Manufacturers should be stimulated to apply for MDR/IVDR certification as soon as possible, even if their Directives certification is not yet close to expiry.
- To increase the number of available EU NBs, the MDR and IVDR designation process timeframes should be decreased.
MDR/IVDR Remote Audits are not Harmonised between the Member States
Following Commission Notice 2021/C 8/01 implementation, only 5% of MDR/IVDR audits are done remotely. A harmonized governance by the Member States/Competent Authorities is needed for MDR/IVDR remote audits. If the pandemic should continue or re-occur in the next years, the NBs are expecting to have practical ways to perform remote MDR/IVDR initial audits and MDR/IVDR surveillance audits. As the MDR date of application is over, the Competent Authorities should agree on the MDR/IVDR audits best practices and allow the NBs to perform the MDR remote audits.
Team NB proposed solutions include:
- Fully authorized initial and surveillance MDR & IVDR remote audits with documented and justified risk-based approach.
- Closer alignment between the Competent Authorities to authorize remote audits.
Impact of COVID 19 on PMCF/PMPF for Legacy Devices
The impact of COVID-19 has been detrimental to healthcare research and development studies mandated under the MDR and IVDR. Team NB has proposed several solutions to improve the healthcare research environment, such as:
- Accepting other types of clinical/performance data to support an MDR/IVDR application when previously agreed PMCF/PMPF data collection was impacted by COVID-19.
- Acceptance criteria for the NB when assessing clinical data impacted by COVID-19.
- Acceptance criteria for the NBs to determine whether PMCF activities conducted under the AIMDD/MDD can continue under the MDR.
- Considerations for the NBs when evaluating clinical/performance data impacted by COVID-19.
In conclusion, if the proposed solutions are considered and implemented by the EU medical device and IVD market participants, the NBs believe that the risk of interrupted medical devices and IVDs could be mitigated. Therefore, the NBs recommend all the device manufacturers to consider these proposed solutions to have a compliant EU market entry. Are you willing to launch your devices in the EU market? Do you need end-to-end support for MDR/IVDR implementation? Consult Freyr – a trusted Regulatory partner. Stay informed. Stay compliant.