medicines-medical devices-regulatory affairs
The legal requirements for the maintenance of medical devices are regulated in: Swiss Good Practice for the Maintenance of Medical Devices (GPI) The “Swiss Good Practice for the Maintenance of Medical Devices” (GPI) is a guideline that explains the requirements…
Last updated: 16 January 2025 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…
The amended regulation on in-vitro diagnostic medical devices (IvDV) came into force on 1 January 2025. With the entry into force of the amended Ordinance on In Vitro Diagnostics (IVDV) today, Switzerland is implementing the extended transition periods in accordance…
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…