medicines-medical devices-regulatory affairs
Last updated: 11 December 2024 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
Last updated: 6 August 2024 This post is an attempt to provide basic information about Swissdamed and progress with its availability. To see the updates, click on ‘+’ sign below. About Swissdamed Swissdamed is Swissmedic’s new database for registering economic…
The TGA has published a list of changes to medical device regulations. The table below is an attempt to present the information in a manner such that it can be read easily. Devices or audit application requirements Changes already in…
Last updated: 23 May 2024 Updates are listed at the end of the post. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination (DDC)…
The MHRA: The proposed framework is still in draft, and the final version would be integral with the future core regulations. With reference to the intended policy on international recognition, the comparable regulator countries (CRCs) for the proposed framework will…
Last updated on 26 October 2024 See history of updates below. This post is an attempt to provide an information resource for the Medical Devices Regulation (EU) 2017/745 (MDR). The information provided is by no means exhaustive or complete. Although…
Date Guidance No About the guidance 12 Mar 2024 MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) When a sponsor of a clinical investigation submits an application according to article…
Last updated: 23 February 2024 See updated at the end of the post. On 23 January 2024, the European Commission published a proposal to extend transition periods for certain in vitro diagnostic medical devices (IVDs), gradual roll-out of Eudamed and an…
On January 31, 2024, the FDA issued a final rule (Medical Devices; Quality System Regulation Amendments) which was published on 2 February 2024 and will become effective on 2 February 2026. Why was the final rule issued? The final rule was issued…
Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…