The EU Regulation (EU Regulation 2017/745) on Medical Devices 2017/745 (Medical Device Regulation MDR) poses particular challenges for medical device manufacturers and other economic actors.
We are happy to support you in the preparation and implementation of the MDR requirements and offer you qualified support that is specifically adapted to your respective medical devices and wishes.
The MDR explicitly underlines the importance of own clinical data for the proof of device safety and clinical benefit. In many cases, it will no longer be possible to gain market access or to maintain the medical device on the market without having to obtain its own clinical data.
In addition, the devices are required to have appropriate market surveillance activities (PMS/PMCF), which must be planned accordingly in a PMS or PMCF plan and are to be evaluated as a report.
The Notified Bodies expect that for the generation of the data established quality control measures and ethical principles (ISO 14155, Declaration of Helsinki) were considered.
Of course, in addition to market approval, cost-effectiveness is an essential topic for you. We advise and support you in the challenge of implementing the requirements of the MDR without losing sight of your economic goals.
Our offer includes, for example:
- Support for required plans and reports
- Post-market clinical follow-up (PMCF plan/report)
- Post-market surveillance (PMS plan/report)
- Summary of Safety and Clinical Performance (SSCP)
- Periodic safety update report (PSUR)
- Review your documentation with the requirements of the MDR with the support of the MDCG guidelines (medical device coordination group)
- Assistance in carrying out and evaluating post-market clinical follow-up activities
- Consultations and training