In an article published on Medical Device Online, Navigant discusses how should companies prepare for MDR
The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyse the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation.
This paper investigates the impact of the new regulations on 5 topics: implications for Notified Bodies, product portfolio, clinical evidence, post-market surveillance and the EUDAMED database. The suggested approach breaks activities down into three subsets: those activities that need to be carried out immediately, those that need to be completed before the MDR comes into force, and those activities that will be ongoing even after enforcement. This approach allows focusing on most urgent activities and those with the longest lead times, while not forgetting other dependent or significant tasks. Following this approach should set medical device manufacturers up for the significant challenge that is the Medical Device Regulation.
After May 2020, MDR non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation.”