Changes in Medical Device Regulations in Europe, Focus on Clinical Data and Evaluations

Since 2012 there has been a draft from the commission to revise the regulations for medical devices. At present time it is in the latest part of being finalized and the expectation is that they will be formally presented in May 2017. There is a lot of changes in the new regulation, as examples it will a requirement for a regulatory person on each company, UDI (unique device identification) in labeling, extended scope (also non-medical devices such as hair/skin removal devices will be regulated), Unannounced inspections etc etc. Also there will be substantial changes with regards to clinical evaluation and clinical data,  there will be higher requirements on having clinical data and also to keep them updated, further it will be stricter requirements for competence for the person involved in clinical evaluations as well as on some devices (some class II and IIb) review by a “scrutiny panel” besides the Notified Body. With regards to the main theme of the conference, an enhanced need for IT & Software solutions to obtain the clinical data will be a vital question for the future.