Advena Guidance on Regulation (EU) 2023/607
This amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the limited capacity of the notified bodies. Since its introduction in March, there have been some notable updates that manufacturers should be made aware of. Advena has created a guidance document that will help ...
MDCG 2022-18 Position Paper – Article 97 of the MDR
Toward the end of December 2022, the MDCG published a position paper aimed at providing a common understanding and approach to the application of Article 97 of the MDR. Giving some hope concerning devices that were certificated under the MDD but have expired since May 2021 or will expire before an MDR certificate is issued. ...
Manual on Borderline and Classification under Regulations (EU) 2017/745 AND 2017/746
September 2022 saw the release of this much-anticipated document, it records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This ...
MDCG Guidance – MDCG 2021-22 Rev.1
A revised MDCG guidance document has been released, MDCG 2021-22 Rev.1 – 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. According to Article 48(6) of Regulation (EU) 2017/746 ...
MDCG 2022-11
MDCG 2022-11 The EU MDCG have published a Position Paper titled “Notice to manufacturer to ensure timely compliance with MDR requirements”. In summary, the document is really a stern warning to manufacturers who have not yet transitioned to the EU MDR, making it clear that those products which do not comply with the regulation requirements ...
MDCG 2022-7: UDI System Q&A
A Q&A document on the EU Regulation’s Unique Device Identification (UDI) system has been published to answer some of the most burning questions when it comes to the application of UDI to medical devices and IVDs. The document covers the following themes: UDI-DI. Basic UDI-DI (BUDI). UDI Labelling. UDI Rules for System and Procedure Packs ...
MDCG 2022-6: Legacy IVD Significant Change
The EU MDCG have published guidance document MDCG 2022-6 to provide clarifications on significant changes as mentioned in Article 110 of the EU IVDR. Manufacturers using this Article in order to continue placing their legacy products on the EU market will know that understanding the meaning of a significant change will be key in continually ...
