On December 6th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This document provides 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 2022-14 (MDCG 2022-17).
This document provides a definition for hybrid audits: it is to 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)”.
It further clarifies how long the presence of the auditor(s) on the auditee’s premises and of the other members of the audit team can last (for the full audit or only a specific part) and also specifies where the conformity assessment activity included in the audit plan can be carried out (either on the auditee’s premises, from elsewhere or simultaneously from the auditee’s premises and elsewhere).
Notified bodies, when establishing their audit plan should make sure to plan sufficient time to audit the relevant processes on the auditee’s premises and identify and clearly document which parts of the conformity assessment activities are carried out on the auditee’s premises or using ICT.
On December 9th, 2022, a new position paper was released by MDCG. This paper outlines the mechanism for manufacturers with expiring MDD/AIMDD CE Marking. It explains how manufacturers can continue placing devices onto the market if their devices are not yet MDR CE Marked. This is to act as a bridging measure until the EU legislation is amended to extend the MDR’s compliance deadline (MDCG 2022-18).
If certification of devices under the MDR has not been finalised before expiry of the MDD certificate, and where the device does not present an unacceptable risk to health and safety, Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) enables competent Authorities (CAs) to require the relevant manufacturer, or its authorised representative, to bring the non-compliance to an end within a reasonable and clearly defined period. This will ensure that the conformity of the devices concerned is established as soon as possible under the conditions set by the CA, while limiting as much as possible the impact on the supply of safe and effective devices to patients and healthcare providers. Important remark is that it should not be regarded as a commonly agreed solution for addressing the expected bottleneck of expiring certificates by 26 May 2024.
On December 12th and December 14th, 2022, the Medical Device Coordination Group (MDCG) released two new guidance documents for devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies.
For these the sponsor should submit an application (Art 66) or notification (Art 70) to the Member State(s) in which the 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 (IVDR). In the absence of the European database on medical devices (EUDAMED), a series of application/ notification documents have been created to support performance study procedures with respect to the IVDR. These templates are included in this document (MDCG 2022-19).
These documents include:
- Performance study – application/notification form under the IVDR
- Addendum to the performance study application/notification form for:
- Additional performance device(s) (section 3)
- Additional comparator device(s) (section 4)
- 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.
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 2022-20).
What does this mean to you?
MDCG 2022-17 clarifies the term hybrid audits and how these are conducted.
MDCG 2022-18 explains how you as a manufacturer can continue to place legacy devices onto the market if their devices are not yet CE marked, making use of Article 97 of the MDR.
MDCG 2022-19 and MDCG 2022-20 are of relevance for all manufacturers that will or are conducting any performance study.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.