Jan 24, 2022

European Notified Bodies have published a new position paper identifying key challenges in terms of ensuring adequate certification support for medical device and IVD manufacturers as the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) take effect.

The position paper, issued by the European Association of Medical Devices for Notified Bodies (Team NB), lays out four major concerns regarding the effects of the new Regulations as well as the coronavirus pandemic on CE Mark certification processes in the European Union (EU), as well as proposed solutions to these challenges.

Notified Body capacity and expiring Medical Device Directive certificates

First, as European Commissioners, industry observers and stakeholders have noted, some Notified Bodies are still in the process of obtaining designation to the new MDR and IVDR. If too few Notified Bodies have obtained appropriate designation before device manufacturers’ existing CE Mark certifications under the Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) or In-Vitro Diagnostic Medical Devices Directive (IVDD) expire, affected devices will no longer be able to be legally sold in the EU, potentially causing supply shortages for healthcare providers and patients.

Numbers provided by Team NB illustrate the challenge:

  • Notified Bodies designated to the MDD: 51
  • Notified Bodies designated to the AIMDD or IVDD: 21
  • Notified Bodies designated to the MDR as of December 2021: 25
  • Notified Bodies designated to the IVDR as of December 2021: 6

The COVID-19 public health emergency has only exacerbated Notified Body efforts to meet existing surveillance activities required under current Directives, ramp up MDR and IVDR certification capacity and obtain requisite designations, according to the Team NB paper. Although European regulators delayed the MDR final date of application from May 2020 to May 2021, some manufacturers that secured extension of their existing MDD certificates in turn delayed submissions of their MDR applications, increasing the likelihood of a capacity crunch over the next few years when they seek out Notified Bodies for MDR certification.

“According to the latest polls performed by Team-NB and the European Commission, the majority of the valid Directives certificates are expiring in the first five months of 2024,” states the position paper.

Team NM proposes the following solutions to address MDR and IVDR capacity challenges:

  • Allowances should be made for manufacturers whose MDD, AIMDD or IVDD certificates have expired but whose MDR or IVDR applications have been accepted by Notified bodies;
  • Regulators should consider extending the IVDR transition period even further beyond May 2024;
  • Manufacturers whose CE Mark certifications to the MDD, IVDD or AIMDD have not yet expired should be “stimulated” nonetheless to apply for MDR or IVDR certification as soon as possible;
  • MDR and IVDR designation process timeframes should be decreased in order to boost available Notified Bodies on the EU market.

Learn more about European MDR compliance and timelines

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.

Learn more about European MDR and IVDR compliance at Emergo by UL:

  • EU MDR 2017/745 gap assessment and CE transition support for medical device companies
  • European IVDR training for IVD manufacturers
  • EU IVDR readiness assessment checklist

Author

  • Stewart Eisenhart

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