MDCG offers guidance on ‘appropriate surveillance’ under IVDR transition period

Regulatory NewsRegulatory News | 20 September 2022 |  By 

The European Commission’s Medical Devices Coordination Group (MDCG) last week issued guidance offering in vitro diagnostic makers and notified bodies clarity on what constitutes “appropriate surveillance” of diagnostics during the In Vitro Diagnostic Medical Devices Regulation (IVDR) transition period.
 
“Devices which are covered by valid certificates issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) may be placed on the market or put into service after the date of application of the IVDR and no later than 26 May 2025 under certain conditions,” MDCG writes.
 
For such devices, MDCG states that notified bodies that issued the certificates under the IVDD must continue to conduct appropriate surveillance of the devices they have certified. “Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 110(3) of the IVDR,” it said. The group also explains that the requirements laid out in the guidance apply to any notified bodies that have issued certificates under IVDD, even if they have not applied for designation under IVDR.
 
For such products placed on the market during the transition period with only certificates valid under IVDD, MDCG stresses that the tests must continue to comply with the IVDD and must not undergo any “significant changes in the design and intended purpose.” Additionally, the approved quality management system must be maintained, and the manufacturer must follow the requirements for postmarket surveillance, market surveillance, vigilance and registration of economic operators and devices under IVDR, which apply to legacy devices.
 
And, until EUDAMED is fully operational, manufacturers should follow the national provisions for registration and surveillance, in line with the harmonized administrative procedures and alternative technical solutions spelled out in MDCG 2022-12. (RELATED: MDCG offers guidance on Eudamed workarounds for IVDR, Regulatory Focus 13 July 2022)
 
For notified bodies, MDCG explains that under Article 110(3) of IVDR, surveillance activities should be a continuation of such activities under IVDD, though notified bodies will “need to take into account the new requirements resulting from the transitional provisions,” and should reference the clarification provided by the Competent Authorities for Medical Devices (CAMD) transition sub-group and other MDCG guidance.
 
Notified bodies should identify, per the manufacturer, the IVDD certificates that will continue to be used and whether their scope will remain unchanged.
 
MDCG stresses that notified bodies “need to ensure that the previous rights and duties under the Directives remain applicable also after the IVDR date of application. This needs to be done on a contractual basis,” and that such contracts should address surveillance activities for legacy devices throughout the transition period.
 
The group notes that notified bodies will need to verify that the scope of devices covered under IVDD certificates remain unchanged and whether the manufacturer has adjusted its quality management system per Article 110(3) of IVDR by reviewing manufacturer quality management system documentation. It adds that notified bodies should verify that manufacturers have made necessary adjustments to their quality management systems and that “all appropriate processes relating to post-market surveillance, including risk management and performance data, feed into the post-market surveillance plan.”
 
Following the document review, notified bodies should adjust their audit program accordingly and identify individual audits and, if necessary, unannounced audits that should be conducted. “Considering the overall intention of Article 110(3) IVDR that certain IVDR provisions already apply to ‘legacy devices’, the audit activities to be performed by notified bodies should focus on those new provisions. In that context notified bodies should combine surveillance activities under the IVDD and the IVDR in a meaningful way,” MDCG writes.
 
When an audit uncovers a major non-conformity that presents an unacceptable risk to public health or patient safety, the notified body must inform the relevant competent authority, MDCG states. Notified bodies must also comply with notification requirements under Article 112 of IVDR when IVDD certificates are suspended, re-instated, restricted, cancelled or withdrawn.
 
When it comes to on-site audits, MDCG lays out four scenarios to consider for on-site audits for IVDD certified devices:
  1. “Manufacturers of ‘legacy devices’ that have not applied for certification under the IVDR (and are not going to adapt or have not adapted their systems to IVDR with the exception to those requirements specified under Article 110(3) IVDR),
  2. Manufacturers of ‘legacy devices’ and IVDR devices that have already implemented the IVDR requirements in their systems and whose application for IVDR certification is being reviewed by the notified body that issued the IVDD certificate(s),
  3. Manufacturers of ‘legacy devices’ and IVDR devices already certified by the same notified body under the IVDR for the same and / or partially different types of devices, i.e. overlapping scopes of certificates,
  4. Manufacturers of ‘legacy devices’ and IVDR devices already certified by another notified body under the IVDR.”
For each scenario, the guidance explains what activities the notified body should undertake during an on-site audit.
 
MDCG 2022-15

 

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