MedTech Europe has released a template to assist In Vitro Diagnostics (IVD) manufacturers in complying with Regulation (EU) 2024/1860. This reg...
EU officially publishes AI Act: Setting standards for trustworthy AI in healthcare
The AI Act was published in the Official Journal on 12 July and came into force on 2 August 2024. The provisions of the AI Act will be ...
Integration of Mandates in Swissdamed!
The Swiss medical device database – swissdamed has gone live this month and actor registrations are open for Swiss entities. For foreign manufacture...
Important News for IVD and MD Manufacturers!
Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to info...
Swissmedic announces new Swissdamed Database!
Swissmedic is pleased to announce the launch of Swissdamed, a new database designed to support the implementation of Swiss regulations for medi...
MHRA proposes a framework for international recognition of medical devices!
The MHRA has announced a policy intent to recognize medical device regulatory approvals from Australia, Canada, the EU, and the USA, aiming to ...
Important News from Swiss Medtech for medical device Manufacturers, Importers and Distributors!
New guidelines have been released detailing the regulatory requirements for placing “legacy devices” on the Swiss market. This is essentia...
Guidance for Clinical Investigation Plan under MDR: Key Highlights!
The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinic...
MDSS receives their ISO 13485 Certificate from BSI!
We’re thrilled to announce that we have received our new ISO 13485 certification from BSI, marking a significant achievement in our commitment...
Commission proposal on extending IVDR transition and expediting EUDAMED adoption!
Due to concerns about manufacturers facing challenges in meeting the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements within the al...