The main media story locally in the UK in January 2024 has to be the Post Office scandal relating to the faulty Horizon IT system and the unjustified prosecution of Post Office Ltd Sub-Postmasters.

For our first blog post of 2024, we would like to share a one page guide to both the PMS report and PSUR. ELIB11 compares the contents of both and provides context as to the applicability of each.

Since the UK left the EU, under the amended UK Medical Device regulations 2002, manufacturers based outside of the UK are required to appoints a UK Responsible Person, based within the UK, in order to place a device on the Great Britain market.

The MDR brings stricter requirements on medical device manufacturers in relation to document and record retention. These requirements are within the spirit of the product liability directive 85/374/EEC

The only point at which manufacturers should rest from their MDR journey is after they have obtained an MDR certificate.