Substance-based medical devices

About the effects of the medical device regulation

Substance-based medical devices

About the effects of the medical device regulation

In the webinar ‘Substance-based medical devices before and after May 26, 2021’. Bernd Brormann, Director Clinical Operations at proDERM, will discuss aspects of the Medical Device Regulation that will come into force on May 26th, 2021 and in particular the implications for the category of ‘Substance-based medical devices’. The following topics will be presented:

  • Background and objective of the new medical device regulation
  • Definition of ‘material medical devices’ – the classification rule 21
  • Risk classes of material medical devices according to old and new regulation
  • Requirements for market approval – clinical trial or proof of equivalence?
  • Regulatory environment
  • Differentiation from medicinal products
  • Active pharmaceutical ingredients in medical devices

The webinar will take approximately 60 minutes and will end with a Q&A session.


Mitarbeiter proDERM

Bernd Brormann

Bernd Brormann is Senior Director Clinical Operations & CRO Services at proDERM. Before joining proDERM in January 2018, Bernd had held several positions in the life sciences industry, including senior management positions in Clinical Operations, Business Development and Customer Relations. Bernd is highly appreciated for his ‘getting-things-done-approach’, which he presumably developed during his early years as CRA and project manager. Today, in his role as Senior Director Clinical Operations & CRO Services, he now takes care of the strategic development of the clinical research unit while at the same time he maintains and expands relationships with clients from the medical device and medicinal products industry. Bernd is member of the “German Society for Good Research Practice” and the “German Society for Pharmaceutical Medicine e. V.”

Norman Kaufmann

Mr. Norman Kaufmann has extensive experience in the medical devices industry and is employed as senior regulatory affairs and project management consultant at NSF PROSYSTEM GmbH. He supports clients in the area of project and quality management, technical documentation, risk management, post-market surveillance, biological and clinical evaluations.

In addition, Mr. Kaufmann has hands-on experience in the development of substance based medical devices and medical device registration in Europe (conformity assessment and CE-marking) as well as in the accompaniment of audits by notified bodies and the competent authorities.

Furthermore, Mr. Kaufmann has interdisciplinary expertise regarding to the regulatory requirements of cosmetic products according to the Cosmetic Regulation including claims and labelling, safety assessment, notification and communication with competent authorities.


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