Lack of harmonized MDR and IVDR remote auditing processes
Second, Team NB notes that a harmonized process for remote auditing across EU member states has yet to be established, with only five percent of MDR and IVDR audits of manufacturers performed remotely since European Commissioners began allowing for remote audits in response to the coronavirus pandemic.
The paper argues that European Competent Authorities should set best practices for audits to MDR and IVDR compliance, and that the European Commission should clarify its Commission Notice 2021/C 8/01 authorizing remote audits if the risk of device supply shortages occur.
Team NB proposed solutions include fully authorized remote auditing processes and procedures for MDR and IVDR compliance, along with fully documented and justified risk-based approaches for such audits that go beyond the scope of Commission Notice 2021/C 8/01. Notified Bodies also suggest closer alignment between Competent Authorities in terms of authorizing remote audits.
COVID-19, PMCF and legacy devices
Third, the ongoing COVID-19 public health emergency in the EU has proven highly disruptive for clinical research, including for post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) studies mandated under the MDR and IVDR.
Team NB suggests several actions to improve the pandemic-era environment for healthcare research, such as:
- Accepting clinical and performance data types beyond PMCF and PMPF to support MDR and IVDR applications;
- New or altered acceptance criteria for alternative data sources and types;
- Acceptance criteria for Notified Bodies to utilize for assessing clinical data affected by the COVID-19 emergency;
- Criteria for helping Notified Bodies determine whether PMCF activities performed according to the MDD or AIMDD may continue under the MDR.
MDCG guidance and harmonization gaps
Last, the Team NB position paper cites the need for additional guidance documents from the European Commission’s Medical Device Coordination Group (MDCG) for various issues related to MDR and IVDR compliance.
As a result, Team NB argues that Notified Bodies should be able to establish best practices on their own in terms of harmonized approaches for surveillance; designation and reassessment processes; and qualification and authorization of personnel, for example.
Conclusion: Device supply shortages still a key concern for Europe
The challenges identified in the new Team NB position paper should be familiar to EU medical device and IVD market participants and observers. While the risk of device supply shortages remains significant as new Regulations take effect in Europe, the paper helps raise awareness as well as potential solutions to ease Notified Body capacity and better support manufacturer compliance.