As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...

UL UK says it will no longer operate as a notified body (NB) under the EU’s medical device directive (MDD) and limit its work under the in vitro diagnostic directive (IVDD). From 1 September, UL UK ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED ...

On 26 September 2012, the European Commission (EC) adopted two proposals that, once adopted by the European Parliament and the Council, will replace the three existing medical devices directives with ...