The Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR) will have a dramatic impact on medical device and IVD manufacturers and everyone associated with the industry. What many stakeholders don’t know – the MDR will also amend the EU Directive 2001/83/EC regarding medicinal products for human use and therefore have a significant impact on pharmaceutical, biotech and biosimilar companies which need a device-constituent part to deliver their medicinal product into the body of the patient.

During his presentation, Beat U. Steffen, founder and CEO of confinis will focus on the following Topics:

  • Main changes in the MDR which amend Directive 2001/83 regarding medicinal products for human use
  • Comparison with Council Directive 93/42/EEC
  • New requirements in Annex I – General Safety and Performance Requirements
  • When will a Notified Body be required for the assessment related to safety and performance requirements?
  • How do I find a Notified Body that has the respective scope to provide an opinion on the conformity of the device part with the relevant general safety and performance?
  • Quality agreements with supplier(s) of device constituent part(s)
  • Aspects to consider during the practical implementation
  • Transition periods – when do sponsors need to be compliant with the Medical Device Regulation (MDR)?

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