Technical Equivalence

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Tuesday, 21 February 2023 - Wednesday, 22 February 2023 (9:00 AM - 5:00 PM) Central European Time

The idea of using a competitor device to establish safety and performance/effectiveness of a medical device to gain market entrance is not a new concept. Both, the European Medical Device Regulation 2017/745 and the FDA FD&C Act 21 U.S.C. § 360c(f)(1) legislation provide a pathway to demonstrate equivalence in relation to other devices. Similarities and differences in the pathways to market access will be elaborated in this session.

In Europe, this concept was first documented in the Medical Device Directive 93/42/EEC and the Active Implantable Device Directive 90/385/EEC, and has since evolved further with significant statutory changes. The directives were repealed and significant amendments introduced with the European Medical Device Regulation (MDR) 2017/745. The MDR (Annex XIV, Part A)) defines that technical, biological and clinical characteristics are considered when demonstrating equivalence to another device to support clinical evaluation, whereas in the US equivalence is a regulatory pathway for market access.

Similarly, the FDA first introduced the concept of a performance based comparison to establish safety and performance/effectiveness, following the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic (FD&C) Act of May 28, 1976. Later, the Safe Medical Devices Act of 1990 added section 513(i), which codified FDA review practice in applying the “substantial equivalence” review standard. The 510(k) program has similarly to European Medical Device legislation undergone several further changes since its establishment. Briefly, the medical device’s classification determines the pathway to market entrance. The majority of medical devices fall under Class II and require a submission under section 510(k) of the FD&C Act to gain clearance to enter the market. The FD&C Act defines that “The Agency bases its decision on whether the device is substantially equivalent (SE) to a legally marketed (predicate) device . Here the supporting evidence needed to establish substantial equivalence to the predicate consists of both nonclinical and clinical performance data.

It is critically important that the clinical characteristics of equivalence are considered by the manufacturer and this should be well documented within the manufacturer’s clinical evaluation report. Whilst the clinical characteristics of equivalence are similar from the AI/MDD to the MDR, there are some subtle changes that need to be considered by the manufacturer to demonstrate conformity. Within the clinical characteristics of equivalence both terms ‘same’ and ‘similar’ are used, manufacturers should be aware of when it is not permissible for differences.

In this session, the speakers will explore the topic of the pathway to establish technical, biological and clinical equivalence for EU conformity versus substantial equivalence pathways for the FDA. Learning objectives are described for each section.

 

 

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Speakers:

Andrea Sparti

Andrea Sparti, PhD
Director Regulatory Affairs, Ypsomed AG

Andrea Sparti, PhD is Director of Regulatory Affairs at Ypsomed AG, a Swiss company, active in the field of drug delivery systems and diabetes care. Following his doctoral degree in biology, Andrea worked in biomedical academic research in Europe and the US for some years. Since 1997, he has been active in the medical device field. During eight years, Andrea worked at Swissmedic, the Swiss competent authority for therapeutic products, where he was responsible for the Medical Device Vigilance team. Since 2007, he has worked in the medical device industry, where he has held RA positions with roles in pre- and post-market functions.

Susana de Azevedo Wäsch

Susana de Azevedo Wäsch, PhD
Vice President Quality Management & Regulatory Affairs & Medical Affairs, Ypsomed AG

Susana de Azevedo Wäsch is vice president of quality management and regulatory affairs with Ypsomed AG. She has more than 19 years of experience in medical devices, pharmaceuticals and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute, Cambridge, England; and the Center for Advanced Research in Biotechnology in Rockville, MD, USA. After earning her MSc at the Ecole Supérieure de Biotechnologie Strasbourg, France, she performed her dissertation at the Institute of Microbiology at the Swiss Federal Institute of Technology in Zurich, followed by further training at the Executive School of Management, Technology and Law in St. Gallen, Switzerland.

Location

Holiday Inn Munich – City Centre
Hochstrasse 3, 81669 München

Room Rate: €139 per night, including breakfast, service charge and statutory value added tax.