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The Regulatory Framework in Switzerland – Ordinances and CH-REPs
Switzerland, though not a member state of the European Union, worked under a mutual recognition agreement (MRA) from 01 June 2002. Fast forward 19 years and the mutual recognition between the 2 territories ended. The European Commission announced in May 2021 that the...
Alternative non-dilutive funding options for MedTech in the UK
MedTech SMEs and startups often look to equity financing and other traditional forms of capital for temporary funding to get through the initial stages of growth, and may end up disregarding debt lending. Equity financing can be a good option for startups working in...
Webinar on UK Responsible Person Requirements – RAPS UK (LNG)
Timothy Bubb will presenting on the role of UK Responsible Person on Tuesday, October 25th with the Regulatory Affairs Professionals Society (RAPS) - UK Local Networking Group. Further details and sign-up links are available here....
1 More Day to Respond to MedTech Europe’s IVDR Transition Survey
IVD manufacturers have 1 more day to respond to MedTech Europe’s 2nd annual survey with the IVD Industry. The deadline is the 21st Oct 2022. MedTech Europe are gathering data from IVD manufacturers and companies planning to CE mark in the near future with the aim to...
Breaking: UK Software and Artificial Intelligence Regulation Roadmap for Medical Devices Published
The UK medical devices regulator MHRA has today published their roadmap on Software and Artificial Intelligence (AI) Medical Device Changes. The change builds upon the previously published MHRA consultation on the future of UK regulation. The strategic approach being...
Postmarket Surveillance
Six years after releasing draft guidance the FDA has released final guidance on device postmarket studies and postmarket surveillance. The issued guidance, published on the 7th of October 2022, provides direction to manufacturers of Class II and Class III devices in...
Manufacturers who sell devices intended for the European market
Great Britain-based device manufacturers who sell devices intended for the European market are also required to have available at least one person who possesses the requisite expertise as specified in the regulations. Article 15 of the EU Medical Device Regulation...
Switzerland’s Medical Device database: Swissdamed
Following the EU's non-renewal of the Mutual Recognition Agreement of conformity assessment (MRA) between the EU and Switzerland, companies will now have to consider 2 sets of legislation for Switzerland and the EU. Switzerland has released requirements for...
New FDA Software Guidance Published to Help Developers Identify if their Software is considered a Medical Device in the USA.
FDA has recently released and updated several final guidance documents for medical device software, which will help software developers identify if their software is considered a medical device in the USA. The first updated final guidance “Policy for Device Software...