The Medical Device Coordination Group (MDCG) has published the following updates:
| MDCG number | Notes |
|---|---|
| MDCG 2021- 23 | Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This guidance is intended to provide assistance to notified bodies to implement requirements established by MDR and IVDR with regard to certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body. |
| MDCG 2021-22 | Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 For class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) establishes the conditions to be applied by the notified body to determine whether it has to consult the expert panel on the performance evaluation report of the manufacturer. These conditions are: (1) the absence of common specifications for the class D device in question, AND (2) where it is also the first certification for that type of device. This guidance provides clarification on the meaning of these conditions and on the corresponding procedures to be followed by the notified body. |
| MDCG 2021-21 | Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices This guidance document concerns 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 Regulation (EU) 2017/746. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and also detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs. The guidance is addressed to all interested parties, including notably the manufacturers, as well as notified bodies and competent authorities, authorised representatives, other market operators, professional and patient associations. The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 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. |
Source: Europa website