February 15th and 16th, 2022, a revision to an existing guidance as well as two new documents were released by the Medical Device Coordination Group (MDCG). An updated version was released of the guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (MDCG 2021-21). The two new documents provide information regarding the verification of manufactured class D IVDs by notified bodies (MDCG 2022-3) and offer guidance 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 (MDCG 2022-4).
MDCG 2021-21 Rev. 1 – Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.
This guidance document addresses the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or IVDR. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs.
The content of this guidance document is envisaged to form the basis for the future common specifications to be adopted according to Article 9 of the IVDR in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.
In this first revision changes have been made to the footnotes of table 1 and 2 with regards to vaccinated individuals. The footnotes of tables 4 and 5 contain additions regarding sample types and in tables 6 and 7 changes have been made to the 1st and 3rd column.
MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies.
Under the Regulation (EU) 2017/746 (IVDR), notified bodies are required to verify product batches of class D IVDs in accordance with Annexes IX and XI. This entails manufacturers providing their notified body the reports on tests carried out on each manufactured batch of class D devices. In addition, the manufacturer should make available samples of manufactured class D devices or batches of devices to the notified body in accordance with pre-agreed conditions and detailed arrangements. The notified body involved in the conformity assessment of the class D IVD should then request one of the EU reference laboratories (EURLs), to carry out batch testing on those devices. The EURL should, in turn, inform the notified body about its findings. Only if the batch passes this verification by the EURL may it be placed on the EU market. In the absence of a designated EURL for a device, the requirements relating to EURLs do not have to be applied.
The MDCG 2022-3 aims to provide guidance to notified bodies to clarify their role and responsibilities and describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs. It also includes guidance on:
- relevant information to be included within the notified body’s procedures
- the content of the required pre-agreed conditions and detailed arrangements between the notified body and the manufacturer
- guidance on the frequency of samples of devices or batches of devices to be sent to the EURL.
MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of MDR.
Article 120(2) and 120(3) of the Medical Device Regulation 2017/745 (MDR) state that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR and no later than 26 May 2024 under certain conditions. One of these conditions is that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance in respect of all the applicable requirements relating to the devices it has certified.
This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance. This guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system.
The document applies to notified bodies that have lawfully issued certificates under the MDD
or the AIMDD, regardless of whether those notified bodies have applied for designation
or are designated under the MDR.
Article 110(3) of Regulation (EU) 2017/746 (IVDR) is outside the scope. However, principles outlined that are common between the MDR and IVDR may also be applied for activities to be performed by notified bodies according to Article 110(3) of the IVDR.
What does this mean to you?
- MDCG 2021-21 Rev 1 is an invaluable guidance for all parties involved in the manufacture and bringing to the EU market of SARS-CoV-2 IVD devices. It addresses the performance evaluation requirements for such devices and forms the basis for a future Common Specification for SARS-CoV-2.
- MDCG 2022-3 contains some very valuable information if you manufacture Class D devices as it will provide you with insights on how notified bodies will approach batch verification testing. It also addresses what should be contained in the agreement between you as manufacturer and the notified body, how a EURL should be chosen, and how a written contract and plan should be drafted between the notified body and the EURL.
- MDCG 2022-4 is of interest if you have medical devices that have a notified body certificate under the directive and that is making use of the transitional provisions captured in Article 120 of the MDR. This guidance addresses how notified bodies should oversee legacy medical devices certified under the former Medical Devices Directive or Active Implantable Medical Devices Directive.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.