medicines-medical devices-regulatory affairs
Last updated: 2 June 2023 See updates at the end of the post. “Blue – Box” requirements “Blue – Box” requirements concern additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of…
The Commission today welcomed the launch of the Unitary Patent system. About the Unitary Patent system The Unitary Patent system: What are the main advantages of the Unitary Patent System The main advantages of the new Unitary Patent system are:…
Last updated: 28 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 24-26 January 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 6 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 13-14 December 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 20 December 2022 See updates at the end of this post. Report and minutes from the CMDh meeting held on 8-10 November 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 28 November 2022 See updates at the end of this post. Anonymisation of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6) EMA has published the…
Last updated: 21 September 2022 See list of updates at the end of the post. Report and minutes from the CMDh meeting held on 19-20 July 2022 The CMDh minutes are a full record of the CMDh meetings (minus redaction…
Updates to the EU Compilation of Union Procedures on Inspections and Exchange of Information, were adopted in September 2021 with a period of 9 months (following publication) before coming into force i.e. June 2022. The changes are relevant for holders of GMP…
On 24 May 2022, the European Commission published a notice to stakeholders on the status of the EU-Switzerland mutual recognition agreement (MRA) for IVDs. Accordingly, affected stakeholders (e.g. manufacturers, EU importers and distributors, authorised representatives) are required to act in accordance…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnosticmedical devices (IVDs) This document outlines the general principles of clinical evidence…