Delegated Acts and Implementing Acts

With delegated acts and implementing acts, the EU Commission has left a back door open for the detailed provision of individual aspects of the EU MDR.Until 25 May 2022, the EU Commission is empowered to adopt specific legal acts (Art. 115 (2)). However, if there is no opposition from the EU Parliament or Council, this period may be extended.More than 40 specific legal acts are intended in the EU MDR. About a quarter of them are delegated acts. Of the remaining 32 implementing acts 8 are compulsory. Implementing acts are expected for various topics as depicted in Art. 86. So far only the implementing regulation 2017/2185 with a code list of devices for the purpose of specifying the scope of the designation as notified bodies entered into force.

Which Implementing Acts are Coming next?

Find below the actual roadmap of the EU Commission for implementing acts with relevants for medical software.

Many Changes are Expected Due to Implementing Acts

Most implementing acts are expected to relate to the operation of Notified Bodies. You can find the complete list of implementing acts mentioned in the EU MDR here:

Definitions and Market Access

  • belonging of specific products, categories or groups of products to medical devices or accessories (Art. 4 (1))
  • uniform application of Annex I (Art. 5 (6))
  • common specifications (Art. 9 (1)) for
    • general safety and performance requirements in Annex I,
    • the technical documentation set out in Annexes II and III,
    • the clinical evaluation and post-market clinical follow-up set out in Annex XIV or
    • the requirements regarding clinical investigation set out in Annex XV

Traceability and Safety

  • designation of UDI issuing entities (Art. 27 (2,11))
  • form and the presentation of the data elements to be included in the summary of safety and clinical performance (Art. 32 (3))
  • detailed arrangements necessary for the setting up and maintenance of EUDAMED (Art. 33 (8))

Notified Bodies

  • uniform application of the requirements for notfied bodies (Art. 36 (3))
  • measures setting out the detailed arrangements specifying procedures and reports for the application for designation of notified bodies (Art. 39 (10))
  • list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies (Art. 42 (13))
  • measures setting out the detailed arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and clinical evaluation documentation (Art. 45 (6))
  • suspending, restricting or withdrawing the designation of notified bodies (Art. 47 (4)
  • measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification for authorities responsible for notified bodies (Art. 48 (5))

Classification and Conformity Assessment

  • interpretation and of practical application of medical device classification (Art. 51 (3-6))
  • harmonised application of the conformity assessment procedures by the notified bodies (Art. 52 (14))
  • extension for a limited period of time the validity of medical device authorisation (Art. 59 (3))
  • establishment of a model for certificates of free sale (Art. 60 (2))

Clinical Evaluation and Investigation

  • interpret­ation and of practical application of clincal evaluation requirements (Art. 61 (13))
  • interpret­ation and of practical application of clincal investigation requirements (Art. 70 (9))
  • assessment procedures for clinical investigations (Art. 78 (7))
  • different aspects of clinical investigations such as electronic forms, electronic system and safety issues (Art. 81)

Post-market Surveillance and Vigilance

  • typology of serious incidents and field safety corrective actions, procedures for the designation of a coordinating competent authority, timelines for the reporting of field safety corrective actions, and all kinds of reports and forms (Art. 91)
  • measures to ensure the protection of health and safety (Art. 96 (3))
  • measures to be taken by competent authorities to address given types of non-compliance (Art. 97 (3))
  • preventive health protection measures (Art. 98 (3-4))

Member States, further Stakeholders and final Provisions

  • provision for expert panels to be designated for the assessment of the clinical evaluation in relevant medical fields (Art. 106 (1)) and designation of expert laboratories (Art. 106 (7))
  • fees for advice by expert panels and laboratories (Art. 106 (13))
  • funding of activities related to designation and monitoring of notified bodies (Art. 112)
  • repeal of regulations 207/2012 and 722/2012 (Art. 122)

Our Recommendations

  • Ensure that there is a responsible person in your company for monitoring the implementing legislation.
  • Establish a process how to get notice of developments in implementing legislation.
  • Ensure that new information from the monitoring of implementing legislation directly reaches the affected departments and adapt your respective processes.
 

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