May 25, 2022

European regulators have issued several new guidance documents relevant to medical device and in vitro diagnostic (IVD) manufacturers days before the In Vitro Diagnostic Medical Devices Regulation’s (IVDR) May 26, 2022 date of application.

The European Medical Device Coordination Group (MDCG) has targeted the following issues related to IVDR as well as Medical Devices Regulation (MDR) compliance:

  • IVDR Article 110(3) transitional provisions regarding “significant changes” to device design and intended purpose (MDCG 2022-6)  
  • Q&A document on Unique Device Identification (UDI) requirements for devices under the MDR and IVDR (MDCG 2022-7)
  • Applying IVDR requirements to legacy IVD devices (MDCG 2022-8)
  • Summary of safety and performance (SSP) template for IVDR compliance (MDCG 2022-9)

Significant changes and IVDR transition periods

First, MDCG 2022-6 clarifies the definition of “significant changes in the design and intended purpose” of IVD devices pertaining to Article 110(3) of the IVDR. Article 110(3) allows for some IVD devices to be marketed in the European Union after the IVDR date of application under certain conditions:

  • IVDs with valid CE Mark certificates issued by Notified Bodies under the In Vitro Diagnostic Medical Devices Directive (98/79 IVDD)
  • IVDs with declarations of conformity issued before May 26, 2022 according to IVDD requirements, and which would require Notified Body involvement to obtain conformity assessment under the IVDR

“The conditions for the application of the transitional provisions in Article 110(3) IVDR are that the devices continue to comply with the IVDD and that there are no significant changes in the design or intended purpose of the device after the date of application of the IVDR,” states the MDCG guidance.

The guidance also provides examples as well as flow charts to help manufacturers determine whether any changes made to their devices’ design and/or intended purpose would be considered significant in terms of IVDR Article 110(3).

MDR and IVDR UDI requirements

Second, MDCG 2022-7 covers several questions regarding UDI compliance for both medical device and IVD manufacturers in the context of the MDR and IVDR. Topics addressed in the guidance include UDI requirements when device package items change; UDI data for single-use reprocessed devices versus original devices; and obligations of economic operators such as distributors and importers to maintain registries of UDI data for devices under their remit.

The guidance also covers medical device model identifiers (Basic UD-DI) requirements, UDI labeling and UDI rules for systems and procedure packs (SPPs) as well as configurable devices, which involve several components that may be assembled in various configurations.

IVDR and legacy devices

Third, MDCG 2022-8 provides further details on how IVDR requirements apply to legacy devices, including obligations laid out in Chapter VII of the new Regulation pertaining to post-market surveillance (PMS), market surveillance and vigilance.

Manufacturers of legacy devices—that is, IVDs with valid CE Marked to the IVDD before May 26, 2022, or IVDs whose declarations of conformity to the IVDD were issued before May 26, 2022 but whose conformity assessments under the IVDR will require Notified Body involvement—will need to meet requirements under the IVDR such as:

  • Post-market performance follow-up (PMPF)
  • Procedures for serious incident reporting, field safety corrective action (FSCA) and trend reporting
  • PMS reporting as well as periodic safety update reporting (PSUR)

“IVDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to ‘legacy devices’,” the MDCG states, although requirements for performance studies do apply to studies undertaken after the IVDR May 26, 2022 date of application.

Summary of safety and performance (SSP) template

Fourth, MDCG 2022-9 provides a template for manufacturers to submit SSPs for validation by Notified Bodies followed by publication in Eudamed, the European medical device and IVD database.

The IVDR requires SSPs for higher-risk Class C and D IVD devices; contents of an SPP should be determined by whether the IVD it covers is intended for self-testing or for only professional users.

Class C and D IVD manufacturers should refer to the SSP template provided by the MDCG for further details on content and format.

Additional European IVDR compliance resources from Emergo by UL:

  • EU IVDR 2017/746 Gap Assessment and CE Transition Support for Medical Device Manufacturers
  • In Vitro Diagnostics Regulation (EU IVDR) Training
  • Usability engineering (UE) support for the EU transition to IVDR service
  • Performance Evaluation – When, What and How to Prepare for EU IVDR webinar

 

Author

  • Stewart Eisenhart

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