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Last updated about 1 month ago
New proposal to amend IVDR and MDR – transitional provisions IVDR – EUDAMED gradual roll-out – Interruption of supply
over 1 year ago
On January 23rd, 2024, the European Commission published a proposal to amend...
New IVDR/MDR overview of language requirements for manufacturers of medical devices
over 1 year ago
On January 17th, 2024, the European Commission EU Health and Food Safety...
New EMA FAQ on medicinal products development and assessment involving a CDx
over 1 year ago
On December 6th, 2023, EMA released a Questions and Answers (Q&As) document...
New MDCG Guidance documents released
over 1 year ago
On December 21st, 2023, the Medical Device Coordination Group (MDCG) released the...
New MDCG Guidance documents released
over 1 year ago
On December 14th, 2023, the Medical Device Coordination Group (MDCG) released 2...
New MDCG Guidance documents released
over 1 year ago
On December 12th, 2023, the Medical Device Coordination Group (MDCG) released the...
Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
over 1 year ago
On 5 December 2023, the European Commission adopted an implementing act designating...
New MDCG Guidance documents released
over 1 year ago
On November 29th, 2023, the Medical Device Coordination Group (MDCG) released the...
New Study supporting the monitoring of availability of medical devices on the EU market – Surveys for MD and IVD manufacturers and authorised representatives
over 1 year ago
The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) –...
New MDCG released!
over 1 year ago
On September 26th, 2023, the Medical Device Coordination Group (MDCG) released a...