As we snap back into action for 2023, here’s a quick roundup of some literature from the MDCG that you might have missed over the holidays…
Application of Article 97 MDR to legacy devices
At the end of last year, the MDCG released their position paper on the application of Article 97 MDR to legacy devices with certificates granted under MDD or AIMDD that expire before the MDR certificate issuance. The paper applies to devices that, after the MDR’s respective date of application, fall within the scope of Article 120(3) MDR and are/were considered to be ‘legacy devices’ within the meaning of MDCG 2021-25.
The document applies to:
- devices that are “in transition” from the MDD / AIMDD to the MDR
- devices for which, despite reasonable efforts undertaken by the manufacturer to obtain MDR certification, the relevant conformity assessment procedure involving a notified body has not been concluded in time
However, the paper does not apply to:
- devices with certificates issued under the MDD / AIMDD that have been suspended or withdrawn by the notified body
- devices that have undergone a significant change in design or intended purpose within the meaning of Article 120(2) MDR
You can access the full paper here.
Guidance on PSUR according to MDR
A Periodic Safety Update Report (PSUR) summarises the results and conclusions of the analysis of post-market surveillance data gathered as a result of the Post-Market Surveillance Plan. The introduction of the PSUR as a requirement within Article 86 of the MDR involves a more consistent, standardised, and systematic review of all Post-Market Surveillance (PMS) data by manufacturers of Class IIa, IIb, and III devices.
MDCG 2022-21 aims to assist manufacturers with the implementation of the legal requirements outlined in Article 86. It applies to:
- medical devices which have been certified under the MDR
- medical devices which have been certified under MDD 93/42/EEC or AIMDD 90/385/EEC except for devices which cease to be placed on the EU market before the MDR date of entry into application
The guidance does not apply to in vitro diagnostic medical devices which have been certified under IVDR or IVDD. A specific guidance is intended for publishing to cover these devices.
Use of hybrid audits under MDR and IVDR
Last December also saw the release of MDCG 2022-17. The paper outlines the MDCG’s position on the possible use of hybrid audits by notified bodies under MDR and IVDR. Since the disruption to the traditional auditing method during the COVID-19 pandemic, caused by the resulting travel restrictions and other health advice, auditors and auditees have become accustomed to the use of information and communication technologies during audits.
As such, MDCG 2022-17 aims to provide a definition for hybrid audits, as well as clarification regarding how hybrid audits can continue to be used under MDR and IVDR. See here for more.
Revision of Manual on Borderline & Classification for medical devices under MDR & IVDR
In the EU, determining whether a product can be defined as a medical device and deciding which classification rules apply as a result, is the responsibility of the authorities in the Member States where the product is marketed. But when interpretation of the EU legislation differs, public health may be put at risk, and the internal market may become distorted.
So, to facilitate an essential dialogue between regulators, as reported in our MedTech news roundup, last September the MDCG released a manual that provides guidance on the qualification and classification of borderline products for medical devices and IVDs in the EU.
The manual presents the agreements reached by the Borderline and Classification Working Group (a subgroup of the MDCG that’s chaired by the EU commission) following the exchanges under the Helsinki Procedure as outlined in the EU MDR and the EU IVDR.
Version 2 of the manual was released by the MDCG in December, and you can access the full document here.
For further advice on topics regarding Regulatory Affairs for medical devices, please do get in touch – our Regulatory team is ready and happy to help. Simply contact us to start the conversation.