MDR support for PMS and PMCF
Addressing the new Regulation (EU) 2017/745 on Medical Devices
The new Medical Device Regulation (EU) 2017/745, better known as the MDR, has been in effect since May 2021. A central aspect is the focus on generating clinical safety data (in the new regulation the word “safety” appears 290 times compared to 40 in the old directive!) and the performance of a medical device.
Compliance with MDR requirements may seem complex, but it represents an opportunity: compared to the past, when many devices were certified for equivalence without clinical data of their own, it is now possible to enter the market with solid evidence from the start. Even for legacy devices, the regulation has introduced more structured criteria, especially for innovative technologies. This approach not only increases the credibility of products, but also improves their competitiveness and acceptance by authorities and healthcare professionals.
I can support you in conducting clinical trials and data collection targeting MDR requirements. I offer assistance in drafting strategic plans (Clinical Evaluation Plan – CEP, PMS Plan, PMCF Plan) and periodic reports (Clinical Evaluation Report – CER, PSUR, PMCF Report, Trend Analysis), helping you ensure regulatory compliance with a robust and structured approach.
In addition, if your device requires a pre-market clinical investigation, I can guide you in assessing the need for a study, helping you define the most appropriate strategy to obtain the data required for certification.
Completed regulatory pathways
I contributed to the clinical evaluation of the following products, successfully supporting their MDR certification, both within the transition period from MDD requirements and through the direct MDR certification pathway.
Manufactured by Sterify Ltd. and distributed internationally by HuFriedyGroup, Sterify Gel is a mucoadhesive hydrogel for the treatment of periodontitis. It has been certified directly in MDR after a pre-market clinical investigation.
