KPMG and the Regulator Affairs Professional Society (RAPS) have published the results of their survey investigating whether companies are ready for the new Medical Device Regulation (MDR) coming into enforcement in 2020.
220 medical device companies were asked about their work towards compliance with the new Regulation, but only around a fifth of the companies claimed to have a “deep understanding and strategy for dealing with the MDR’s impact”. Twice as many felt they had no (or little) understanding, giving reasons of concern for the industry as a whole.
An Emergo article, delves into the study and draws out some important recommendations, such as:
- “Assign staff and allocate resources to read and become more familiar with the MDR and its requirements;
- Establish and align cross-functional resources and staff to forecast and prepare for business and operational impacts of the new Regulation;
- Consider MDD and/or Active Implantable Medical Devices Directive (AIMDD) recertification under the current grace period in order to mitigate delays in MDR certification due to Notified Bodies’ capacity challenges;
- Establish cross-functional teams to manage relationships with economic operators and meet new supply chain requirements under the MDR
- Develop post-market surveillance (PMS) systems with strong links to risk management functions to help manage quality requirements for new as well as legacy devices in firms’ product portfolios;
- Develop and implement data collection strategies to address MDR’s PMS requirements as well as compliance with the Eudamed medical device database”