Europe: Notified Bodies in Europe Provide Updates on MDR and IVDR Implementation Challenges

On 1 December 2021, the European Association for Notified Bodies (Team NB) released a position paper to address concerns regarding the implementation of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR).

Given that Active Implantable Medical Device Directive (AIMDD), Medical Device Directive (MDD), and In-vitro Diagnostics Device (IVDD) certificates will cease to exist in 2022, 2023 and 2024, Team NB has concerns regarding the potential shortage of medical devices and IVDs for patients in Europe. Hence they have highlighted four of the major concerns they have, as well as their proposed solutions.

Concerns

1. NBs in 2022,2023 and 2024 given the amount of expiring AIMDD, MDD and IVDD certificates

There is a significant number of Notified Bodies still in the process of acquiring appropriate designation to the new MDR and IVDR. In essence, if there not enough Notified Bodies when the existing AIMDD, MDD and IVDD certificated expire, affected devices will no longer be a allowed to be sold in the EU, leading to a shortage in medica devices for healthcare providers and patients. As mentioned in the paper, currently there are 25 NBs for MDR and only 6 for IVDR, as compared to 51 for MDD, 21 for IVDD. In addition, the IVDR certification process is also longer than that for IVDD.

The challenging situation is worsened by the current Covid-19 public health emergency, on top of the Directive surveillance work that needs to be carried out under the existing regulations. Despite the deadline for MDR being postponed to help ease the work crunch, this led to many manufacturers delaying their application submissions. This is a cause for concern as majority of the Directive certificated for NBs are expiring in the first five months of 2024, and this will lead to a major bottle-neck when manufacturers seek out NBs for MDR certification.

These are Team NB’s proposed solutions

• Options should be examined for allowing toleration of manufacturers whose Directives certificates expired prior to successful completion of MDR/IVDR certification for as long as there is evidence of an MDR/IVDR application successfully accepted by a notified body

• A further extension of the IVDR transition period beyond 26 May 2024 should be examined (e.g. until 26 May 2025) considering very limited grace period

• 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

• • MDR/IVDR designation process timeline should be shorter to increase the number of available NBs as quickly as possible

2. MDR and IVDR audits are not harmonized between member states Currently, since the introduction of remote audits due to the Covid-19 pandemic, only 5% of MDR and IVDR audits are conducted remotely. This is because there is no established method of conducting remote audits. In light of the amount of MDR an IVDR certificates to be issued, competent authorities should agree on the best practices for remote audit, or face greater risk of a device shortage. Team NB’s proposed solution:

• Authorized Initial and Surveillance MDR & IVDR remote audits with documented justified risk based approach and not only under "risk of shortage conditions" as per Commission Notice 2021/C 8/01

• Alignment between Competent Authorities to authorize remote audits

3. Impact of Covid-19 on PMCF/PMPF for legacy devices The Covid-19 pandemic has been very disruptive for healthcare research and development, including Post-Market Clinical Follow-up and Post-Market Performance Follow-up studies, which are still required under MDR and IVDR. Team NB’s proposed solution:

• Acceptance of other types of clinical/performance data that may be collected to support an MDR/IVDR application when previously agreed PMCF/PMPF data collection has been impacted by Covid-19.

• Acceptable criteria of alternative data e.g. remote survey considerations, remote assessment data

• Acceptance criteria for the notified body to consider when assessing clinical data impacted by Covid-19

• • Acceptance Criteria for when notified bodies can allow for PMCF activities conducted under the AIMDD/MDD (that have not completed due to the pandemic) that can continue under MDR

• Considerations for notified bodies when evaluating clinical/performance data that has been impacted by Covid -19 pandemic e.g. availability of medical alternatives, PMCF/PMPF follow up intervals, reducing MDR/IVDR certificate validity to coincide with data collection.

4. Harmonization gaps in MDCG guidance

There is also a need for more guidance documents from the Europeans Commission’s Medical Device Coordination Group (MDCG) for issues related to MDR and IVDR compliance. Team NB’s proposed solution

• NBs should be entitled to establish “good practices” for a harmonized approach. These documents could be prepared endorsed at the Team-NB level as the 1st step. In a 2nd step, the paper could be updated/endorsed by NBTG and then NBCG-Med.

Conclusion

Team NB believes that if their proposed solutions are taken into serious consideration, risk of medical device supply interruptions could be mitigated, and these solutions would also be important in the event of other public health emergencies in the future.

Sources

Notified Body position paper on MDR/IVDR Implementation.

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