22. January 2018
After the Brexit manufacturers need to find a new Authorized representative and a new Notified Body if they use these service Providers in the UK.

18. January 2018
FAQ for the application and transition of the MDR (EU)2017/745

07. December 2017
The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES". The document is intended to act as a guidance for the interpretation of the MDD and IVD. The new paragraphs introduced by the updated are identified by the Picture "New". Important notice: This document is not applicable under the MDR unless further updates will integrate the reference to the (EU)...

04. December 2017
The Australian Authorities published the new fees applicable to medical devices as of December 4th, 2017. The table with applicable fees is available on the TGA Website.

29. November 2017
The newly published document on the "AO Availability to Conduct MDSAP Audits" still only includes 4 Auditing organizations that were recognized by the Council in full: BSI Group America Inc. Intertek Testing Services NA Inc. TÜV Süd America Inc. UL Medical and Regulatory Services Inc. The other 10 Auditing Organizations on the list still need to finish the last steps for recognition.

26. November 2017
Switzerland paves the road for the implementation of the MDR requirements into national legislation.

23. November 2017
Three days prior to the application date for the future Notified Bodies the EU commission published the final version of the first Implementing Act „Codes for Designating Notified Bodies“ under the MDR. Although it is still missing the official document registration number it was used for the first applications send by the Notified Bodies to their national accreditation Bodies. The previous draft version of the Implementing act is now obsolete. As mentioned for the draft this document may...

20. November 2017
The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest. What is the impact for medical device manufacturers? For consultation procedures under the MDD and under the MDR, it is part of the conformity assessment procedure with the notified by to contact either the local Authority or the EMA. More concerning the relocation details can be...

17. November 2017
The EU-Commission published an updated list of harmonized standards on their website. The new publication includes among other newly harmonized standards the EN ISO 13485:2016 as harmonized for the 3 directives: 90/385/EEG AIMD 93/42/EEC MDD 98/72/EEC IVD Please be reminded that this does not imply the presumption of conformity under the (EU)2017/745 MDR.

14. November 2017
Following a publication issued today by the EU commission the joint assessments of the potential Notified Bodies under the MDR and IVDR will be a challenge but all participating parties are well prepared. The publication further explains the sequence of assessment will follow the receipt of the preliminary assessment reports by the competent authorities.

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