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Regulation, Regulation, Regulation





The EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) introduce substantial changes that impact all manufacturers of medical devices. However, these regulations also have implications for pharmaceutical companies producing drug device combination products or companion diagnostics. Understanding the new requirements and implementing them is of the utmost urgency as the deadlines for compliance are approaching fast (May 2020 and May 2022 respectively), and products containing non-compliant devices after these deadlines will have to be withdrawn from the market.

The new device regulations are complex and are causing unprecedented upheaval in the industry. The further difficulty for pharma businesses is the lack of familiarity with the MDR and the fact that they may have to liaise with a notified body for the first time.

 

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About the author


Elizma Parry brings over 25 years of experience to the Maetrics team and provides clients with expert counsel in the clinical practice environment. As a highly qualified industry professional, Elizma is a proven leader with a strong track record of clinical safety, regulatory, and quality management experience. Having recently been in a shared acting role as the head of a Europe-based notified body before joining Maetrics, she was also managing a multi-national clinical team within the notified body that was responsible for the clinical safety, performance, and clinical benefit conformity assessments of medical device manufacturers’ clinical evidence, as well as the lead for liaising with the Medicines and Healthcare products Regulatory Agency. Elizma has also worked across quality, regulatory, and biotechnology environments throughout her career. She has developed and presented training courses across the UK and US, including joint development of a bespoke Cranfield University course for notified body clinical assessors.


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