The medical device industry has never faced such crucial and extensive changes as MDR before.
The publication of the EU Medical Device Regulation 2017/745 NOT ONLY affects the NEW devices that medical device manufacturers aim to put on the European market but also all devices currently being sold under CE marking, and thus, the future of the manufacturer.
Therefore, we recommend that you proceed in line with the following plan for the MDR within the completion dates you will determine.
- Perform a gap analysis or seek help to have such analysis performed taking EU 2017/745 – MDR rules into account.
- Inform and train your team about MDR as much as possible.
- Determine the costs of the requirements mandated by the MDR to your firm.
- Make feasibility studies for all your products (taking the estimated strategy of global competitors into account) according to revenue and profitability.
- Assign your employees or hire a consultant to follow changing standards and guidance documents.
- Find out which Notified Body in Europe you can work with against the worst-case scenario.
