The Road Map to Authorization in the EU
Sterile Medical Devices must follow the regulations and standards for CE marking that went into effect May 2021. Medical devices being sold in Europe require a CE mark, even if the product is imported from outside the Economic European Area (EEA). CE marking certifies that a medical device complies with regulatory requirements under European Regulation (MDR 2017/745 and IVDR 2017/746). Upon receipt of the certification / CE mark the product can be freely marked, sold, and marketed anywhere in the Economic European Area (EEA).
In this webinar, the strategic process of obtaining a CE mark, the defined product use and classification, as well as conformity assessment will be covered. Additionally, the interaction and experiences with contract sterilizers regarding MDR will be reviewed, including key validation information required for obtaining a CE mark for a sterile product.
Medical device manufacturers developing new products or improving the design, or packaging of new or existing products are invited to register for this free webinar to gain a greater understanding of the:
- The process to obtain a CE mark and certification under updated EU and ISO regulations.
- Ensure compliance with regulations and product/process safety.
- Understand the interactions with a contract sterilizer, for the validation process and submission requirements to obtain a CE mark for a sterile medical device.
About the Speakers
Marie-Pierre Hildebrand, RA/QA Director, EMEAA, Sterigenics.
After completing her master’s in Industrial Pharmacy, Marie-Pierre started her carrier as a Process Supervisor in the production of vaccines and then move to a role as a Clinical Trial Manager. After a couple of years in the Operations part of the business, she continued her education with a master’s in Management in order to take a role in Business Development. Marie-Pierre started at Sterigenics 7 years ago as the Responsible Site QA for an EO facility as well as executing the role of Qualified Person per EU regulations for pharmaceutical products. Marie-Pierre assumed the role of RA/QA Director for EMEAA 3 years ago and ensures the QA oversight of 11 EMEAA facilities for both RADIATION and GAS technologies. Marie-Pierre is also a Pharmaceutical Quality Systems Auditor. Marie’s Expertise includes Deep knowledge in both EU regulatory requirements as well as global sterilization requirements. She is listed as an EU-registered Qualified Person and Lead GMP and ISO 13485 auditor.
Seyed Khorashahi, Executive Head of Medical Devices, Regulatory Compliance Associates.
Seyed Khorashahi has more than 25 years experience leading R&D teams in all aspects of developing safety-critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy. Seyed has significant domain expertise in U.S. Food and Drug Administration (FDA) and EU standards, as well as in software systems and hardware development for medical devices. In addition, Seyed is adept at using strong analytical and technical skills to lead teams in solving complex problems and fulfilling the voice of the customer. He has a proven track record of efficiently deploying process improvements with extensive knowledge of 21 CFR 820 and ISO 13485.