Medical Device Coordination Group (MDCG) updates -October to December 2022

Guidance NoAbout the guidance
MDCG 2022-4 rev.1Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, Revision 1 – December 2022

There are amendments throughout the document to align it with MDCG 2022-15 (Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)) and to reflect the views of MDCG as expressed in action no3 of MDCG 2022-14 (Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs) .


MDCG 2022-21Guidance on periodic safety report according to Regulation (EU) 2017/745 (MDR) – December 2022

The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the Medical Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement under the MDR requires a more consistent, standardized and systematic review of all Post-Market Surveillance1 (PMS) data by manufacturers of class IIa, class IIb and class III devices.

The main objective of this guidance document is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR. However, manufacturers should have reasonable time to adapt their quality management systems and sufficient flexibility when they draw up and update a PSUR as long as they can demonstrate that it is in line with Article 86 MDR.
MDCG 2022-20Substantial modification of performance study under Regulation (EU) 2017/746 – December 2022

The sponsor of a performance study is required to submit an application/notification to the Member State(s) in which a performance
study is to be conducted, accompanied by the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR). The application/notification must be submitted by means of the electronic system referred to in Article 69 of the IVDR.

Additionally, the sponsor of a performance study is required to notify the Member State(s) in which a performance study is being or is to be conducted if it intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the performance study by means of the same electronic system.

In the absence of the European database on medical devices (EUDAMED), a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR – see MDCG 2022-19.

To add to these documents, a template for ‘Substantial modification of performance study under Regulation (EU) 2017/746’ is also provided.

Insofar as possible, the modification of the performance study form includes the same data fields as the EUDAMED system in development
MDCG 2022-19Performance study application/notification documents under Regulation (EU) 2017/746 – December 2022

The sponsor of a performance study is required to submit an application/notification to the Member State(s) in which a performance study is to be conducted, accompanied by the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR). The application/notification must be submitted by means of the electronic system referred to in Article 69 of the IVDR.

In the absence of the European database on medical devices (EUDAMED), a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR.

These documents include:
· Performance study – application/notification form under the IVDR
· Addendum to the performance study application/notification form for:
o Additional performance device(s) (section 3)
o Additional comparator device(s) (section 4)
o Additional site(s) (section 5)
· Performance study supporting documents – Appendix of documents to attach
· Checklist of general safety and performance requirements, standards, common specifications and scientific opinions

Insofar as possible, the performance study application/notification form includes the same data fields as the EUDAMED system in development.

For further guidance with respect to the application of certain IVDR provisions in the absence of EUDAMED please see MDCG 2022-12 . In the absence of EUDAMED, the Union-wide unique single identification number for a performance study, to be used for all relevant communication in relation to that performance study, will be the CIV-ID which can be generated in Eudamed, the electronic
system which supports the medical device Directives.
MDCG 2022-18MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate

This document:
· aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR. The use of Article 97 MDR in those situations is meant to be a temporary solution. It will contribute to avoiding disruption of supply of devices on the EU market needed for health systems and patients. This document should not be regarded as a commonly agreed solution for addressing the expected bottleneck of expiring certificates by 26 May 2024.
· describes how CAs intend to apply Article 97 MDR in a legally sound, coherent and consistent manner to deal with devices that, after 26 May 2021 (i.e. MDR’s date of application), fall within the scope of Article 120(3) MDR and for which the MDD or AIMDD certificate has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.
MDCG 2022-17MDCG position paper on ‘hybrid audits’

This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

It is recognised that there was a disruption to the traditional auditing method during the global COVID-19 pandemic due to travel restrictions and other health advice at that time. Since then, auditors and auditees have become accustomed with the use of information and communication technologies (ICT) during audits as described in MDCG 2020-4 and MDCG 2020-17. This paper aims to provide a definition for hybrid audits and clarifications with respect to how hybrid audits can be used under MDR and IVDR as advised following the publication of MDCG 2022-143.

A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s) and/or subcontractor(s) with at least one auditor present on the premises and other members of the audit team participating from elsewhere using information and communication technologies (ICT).
MDCG 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – October 2022

This guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the Regulations. Where clarification is already covered by other MDCG guidances, this guidance on authorised representatives includes a reference.

The requirement to have an authorised representative is not applicable to devices intended for clinical investigation (MDR) or performance study (IVDR). To this end, Article 62(2) MDR and Article 58(4) IVDR state that ‘where the sponsor of a clinical investigation or performance
study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative’. As the legal representative is not defined as the authorised representative, these requirements are not further included in this guidance.
MDCG 2019-6 Rev.4 Oct 2022
Questions and answers: Requirements relating to notified bodies.

In this revision, the following question and/or its response has been revised:

III.6. What is the meaning of the term “employed” in MDR Article 36(1) / IVDR Article 32(1)?