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 ???????????????????????????? ???????????????????????????? (????????????????-???????????????????????? ???????????????????????????????????????????????? ????????????????????????????????????????????????) (????????????????????????????????????) (???????????????????? ????????????????????????????) ???????????????????????????????????????????? ???????????????? 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. ???????????? ???????????????????????????????????????? ????????????????????????????: ???????????? ???????????????????????? ???????????? ????????????????: 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. ???????????? ????????????????????????????????????: Gradual Implementation: EUDAMED modules will be introduced progressively, following independent audits and confirmation of functionality. ???????????????????????????????????? ????????????: 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