Last month, the Medical Device Coordination Group (MDCG) published two important guidelines.
MDCG 2022-3 “Verification of manufactured class D IVDs by notified bodies” is the first one and provides information on conformity assessment procedures for class D in Vitro Diagnostic – Medical Devices (those at the highest risk).
MDCG 2022-4 “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR” is the second one and focuses the attention on the surveillance process regarding legacy devices, namely those devices that are allowed to remain in the EU market until May 2024 because they are covered by valid certificates issued under the Active Implantable Medical Devices Directive (AIMDD) or the Medical Devices Directive (MDD).
Below there is a brief summary of the main topics addressed in each of the two guidelines.
A conformity assessment guideline on high-risk IVD devices
According to IVDR (EU) 2017/746 Regulation, class D in Vitro Diagnostic – Medical Devices at high risk must undergo a particularly sophisticated conformity assessment procedures which requires the involvement of Notified Bodies and EU Reference Laboratories (EURL) subjected to rigorous testing.
Class D devices particular conformity assessment procedures are aimed at minimising possible health risks to patients.
Firstly, class D IVD devices Manufacturers must submit reports of the tests carried out on each batch of devices and deliver samples of these products to the appointed Notified Body (NB).
Afterwards, the Notified Body should request one of the EURL laboratory to carry out batch testing on those devices. The findings should be sent back to the Notified Body that, as the ultimate responsible for the verification process, must examine the final results. Class D IVD devices can be placed on the EU market only if they successfully fulfil this test.
MDCG 2022-3 guideline is very useful for Manufactures because it clarifies the procedures for authorising the placing on the market of such high-risk class D devices.
MDCG 2022-4 on legacy devices surveillance
Article 120 of MDR (EU) 2017/745 Regulation on Medical Devices establishes that legacy devices in accordance with the previous directives AIMDD or MDD are allowed to remain in the EU market until May 2024, as long as the Notified Body that issued the certificate keep carrying out appropriate post-market surveillance, in compliance with supervisory requirements.
MDCG 2022-4 guideline outlines the activities that need to be carried out by the Notified Body (NB) in order to manage the surveillance of quality management systems for legacy devices.
Furthermore, Manufacturer’s duties are made clear, including providing the NB with safety and post-market surveillance reports, in order to allow it to carry out the necessary checks on the quality management system.
The Analysis of this guideline is a must if you have legacy devices under MDD or AIMDD.
Find out more about how we can support you in complying with MDR (UE) 2017/745 and IVDR (UE) 2017/746 Regulations
Thema’s experts can help you in the process of achieving compliance with the requirements of MDR and IVDR Regulations.
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