December 9, 2022
The MDCG published new guidance on how to market under MDR Article 97, after an MDD/AIMMD CE certificate expires. Find out who is eligible and how to apply.
December 9, 2022
The EU Council confirmed they will present a legislative amendment in early 2023 to postpone the May 2024 MDR deadline, and more. Find out more here.
December 6, 2022
The MDCG released a new position paper on 'hybrid audits'. Click here to read the definition and to which situations it applies.
November 11, 2022
The MDCG released a new guidance document on EU Authorized Representatives (ARs). Find out the contractual obligations between Manufacturers and ARs here.
November 8, 2022
There is an extreme lack of transparency regarding Notified Body fees and timing. Find out how to combat this and get access to fee & capacity information here.
November 1, 2022
The EU Commission published Notified Body statistics related to MDR/IVDR certification. Find out the average MDR/IVDR CE Marking processing times and more.
September 28, 2022
Team Notified Body (NB) has issued a Position Paper on transition timeframes to implement new MDCG guidance and best practice documents into procedures. Find out timeframes here.
September 26, 2022
Team Notified Body (NB) published a position paper on hybrid audits for medical device certification. Find out here their recommendations and criteria.
September 7, 2022
The Borderline and Classification Working Group released the September 2022 ‘Manual on Borderline & Classification' for medical devices and IVDs. Find out more.