The EU Medical Device Regulation (MDR): Focus on stricter requirements and clinical investigations

The innovations in the EU Medical Device Regulation (2017/745, MDR), if strictly implemented, will mean that equivalence via comparator products will no longer be recognised.

‍Inthis case, separate clinical investigations must be carried out before placing on the market. In addition, clinical data must also be collected, documented and analysed after placing on the market. For medical devices in risk class III, this will tend to become the rule with only a few exceptions. Clinical investigations will also be necessary for new medical devices included in the MDR.

The Medical Device Regulation (EU MDR 2017/745) came into force on 26 May 2021 after the transitional period and a postponement of one year due to the pandemic, supplemented in Germany by the provisions of the Medical Device Law Implementation Act (MPDG) and intended for implementation. The MPDG specifies national implementation rules and concretisations for Germany and significantly exceeds the requirements of the EU MDR.

The main changes brought about by the MDR:

• Extension of the scope of application of the MDR (also to products without an intended medical purpose)
• Establishment of an EU database on medical devices (EUDAMED)
• Higher qualification of products (including medical software)
• Allocation of a UDI (Unique Device Identification)
• Changes in relation to notified bodies
• Designation of a person responsible for regulatory compliance (PRRC)
• Clinical evaluation

Regulation (EU) 2017/745 on medical devices (EU MDR 2017/745) defines clinical evaluation (Annex XIV, Article 61) in addition to clinical investigations (Annex XIV, Articles 62-82).

• post-market clinical follow-up (PMCF, Annex XIV) and post-market surveillance (PMCF, Annex XIV).
• post-market surveillance (PMS, Article 83) are regulated.

regulated.

The clinical evidence for PMCF and PMS can be obtained via observational studies in compliance with the regulations.

The MDR brings significant changes and stricter requirements for medical devices. Companies must prepare for comprehensive clinical investigations and continuous data collection to ensure the conformity and safety of their products.

(Status 2018)

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