Regulations

Switzerland Market Situation Switzerland Market Situation – Downside Switzerland- Medical Device Regulations Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturers Outside Swiss – Proxy to the foreign manufacturer – Responsible for product safety – Liable for product defects – contact person for Swiss authorities – can be a legal entity or a natural person – must have access to PRRC Roles of Swiss AR’s PRRC Liability of a Swiss AR Manufacturer Re...

UK Medical Device Regulations Role of MHRA UK Approved Bodies Authorised Representatives Importer & Distributor Registrations in Great Britain Registration Data • Copy of Declaration of Conformity• E-copy of technical documentation• Device Certificate as granted by the Notified Body• Quality Management Certificate• Database information Manufacturing details• Letter of Designation• Contact persons and list of importers• Database information Device Details• Database informati...

Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices. In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices. MHRA Guidance on Medical Devices Software Medical Devices or not Classifying software or a mobile app as a medical device can be challenging. If t...