With the entry into force of the EU Regulation 745/2017 (MDR), which will be fully and mandatorily applicable from May 26, 2020, manufacturers of medical devices must consider both timing and methods to comply with the required regulatory changes.
GREATER SAFETY WITH MEDICAL DEVICES REGULATION 745/2017
At the heart of the new MDR is the goal of improving the quality and safety of medical devices available on the EU market. With this objective in mind, the requirements that must be met by all stakeholders—and especially manufacturers—have been further clarified and made more stringent. A significant impact concerns the classification criteria for medical devices incorporating substances, and the strictest changes involve documentation aspects, evaluations and clinical investigations, as well as post-market surveillance.
PHARMA mastery, CONSULTANT IN THE MDR FIELD
Our PHARMA mastery division offers support to companies in responding to the demands of the new regulatory update. In particular, thanks to our decades-long experience in toxicological data research and evaluation, in defining safety testing plans, and in the coordination and monitoring of the studies themselves, we are the ideal partner for medical device manufacturers looking to develop an integrated strategy to carry out a biological safety assessment of their products according to the new regulatory requirements for marketing in the European territory.
We remind you that in May 2018, the updated version of the manual on borderline products and classification for medical devices (version 1.22) was published.
Three new borderline cases were introduced: automated external defibrillator (AED) units, lubricants for relieving vaginal dryness, and decision-support software for medicines.
For more information on these activities and to request consultancy on Regulation 745/2017 for medical devices, you can contact the head of the Pharma division, Michela Lomazzi.