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European regulations and directives

The Medical Device Regulation (MDR, (EU) 2017/745) and the In Vitro Diagnostic Device Regulation (IVDR, (EU) 2017/746) replaced the Medical Device Directives (MDD) and the In Vitro Diagnostic Device Directive (IVDD) as of January 2017. The deadline for transition was initially set at 25 May 2021, and after an extension, this remained the latest deadline. In the meantime, some transition periods have been extended a further time

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Medical devices and in vitro diagnostic medical devices that have not been converted in accordance with the new regulations of the MDR and IVDR may only be marketed until the expiry of the validity of their CE certification, which is usually five years after notification. The main difference is mainly more extensive technical documentation but goes beyond this aspect. Expert knowledge is crucial in many sub-areas.

The CE marking

CE marking is essential for placing medical devices, in vitro diagnostics, and active implantable medical devices on the market within the EU. Our expertise enables us to find cost-effective and innovative solutions to support your products throughout their life cycle. Thanks to our close relationships with Notified Bodies and relevant authorities, we can develop a tailor-made strategy for your product to save costs and time and shorten your time-to-market.

We proceed according to the following steps:

  • Product classification and selection of the appropriate Declaration of Conformity.
  • Preparation of preclinical and clinical evaluations.
  • Supporting product development.
  • Conducting compliance tests to ensure that regulatory requirements are met.
  • Selection of a competent Notified Body or Authority and coordination with them.
  • Definition of combination products, if applicable.
  • Differentiation of borderline products and development of appropriate strategy for market approval.
  • OEM / PLM support for original equipment manufacturers or product life cycle management.

Through these steps, we support you to go through the CE marking process effectively and efficiently and facilitate your market access.

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