Regulatory Updates

Swissmedic has just released the 2025 edition of the Swiss Good Practice for the Maintenance of Medical Devices (GPI V2). This updated guidance provides essential recommendations to ensure compliance, patient safety, and the optimal performance of medical devices throughout their lifecycle. 🔍 Key updates in the 2025 edition: ✔️ Revised maintenance standards aligned with the latest regulatory requirements […]

The MHRA has published new guidance on device characterisation, regulatory qualification, and classification: 👉 Digital Mental Health Technology – Regulation and Evaluation for Safe & Effective Products This guidance is applicable to Digital Mental Health Technology (DMHT) products placed on the UK market, covering Great Britain (England, Wales, Scotland) and Northern Ireland. It explains the

On 5 February, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a Nanomedicine Decision Tree—a structured tool designed to guide manufacturers, developers, and regulatory professionals in determining the appropriate regulatory pathway for nanomedicines. This decision tree aims to support researchers and developers in navigating the application of various guidelines from the International Council

The 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 (𝐏𝐨𝐬𝐭-𝐦𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬) (𝐀𝐦𝐞𝐧𝐝𝐦𝐞𝐧𝐭) (𝐆𝐫𝐞𝐚𝐭 𝐁𝐫𝐢𝐭𝐚𝐢𝐧) 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝟐𝟎𝟐𝟒 introduce new post-market surveillance (PMS) obligations for medical device manufacturers in Great Britain by adding Part 4A, which outlines requirements for monitoring device performance and safety after market introduction. 𝐊𝐞𝐲 𝐜𝐨𝐦𝐩𝐨𝐧𝐞𝐧𝐭𝐬 𝐢𝐧𝐜𝐥𝐮𝐝𝐞: 𝐏𝐌𝐒 𝐒𝐲𝐬𝐭𝐞𝐦 𝐚𝐧𝐝 𝐏𝐥𝐚𝐧: Manufacturers must establish a PMS system and develop

The European Commission has released an updated Q&A document on the gradual roll-out of EUDAMED, now accompanied by a helpful flowchart. 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬: Gradual Implementation: EUDAMED modules will be introduced progressively, following independent audits and confirmation of functionality. 𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐔𝐬𝐞: Each module becomes mandatory 6 months after the publication of a notice in the Official Journal

New year starts with amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO) in order to restore euqivalence to EU IVDR (EU 2017/746). It includes: – Extension of tranisitional provisions for medical device certification – Permanent simplification of mandatory labelling for devices dispensed by professionals – Product registration obligation enters into force at 1st

Manufacturers are obliged beginning from 10th January 2025 to notify authorities in case of discontinuation or interruption of supply of certain medical devices. Which devices? All models or types of devices, placed on the Union market and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or

New year starts with amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO) in order to restore euqivalence to EU IVDR (EU 2017/746). It includes: – Extension of tranisitional provisions for medical device certification – Permanent simplification of mandatory labelling for devices dispensed by professionals – Product registration obligation enters into force at 1st

Yesterday, MDCG published draft guidance with useful recommendations for content of Investigator’s Brochure for Clinical Investigations Important note: draft document See full document here: https://www.linkedin.com/feed/update/urn:li:activity:7186772498154168322

See full document here:  https://www.linkedin.com/feed/update/urn:li:activity:7186313929193574400