Technical File consulting and audit

Technical File consulting and audit

Technical File consulting and audit

The EU Medical Devices Regulation (MDR) was published on 5 May 2017 in the EU Official Journal together with the IVD Regulation. The regulation officially came into force on 25 May 2017. After a three-year transitional period, the MDR is mandatory from 26 May 2020. In the opinion of BVMed, however, the transitional period is too short in view of the extensive new requirements placed on Notified Bodies, the clinical evaluation of medical devices, new planning and reporting obligations and the new EUDAMED/UDI database system.

The new EU legal framework will not simplify the placing of medical devices on the EU internal market, as initially promised by the Commission, but rather complicate this process. The MDR, for example, contains more than 100 articles more than the previous Directive (MDD). The number of annexes will increase from 12 to 16. The MDR will also be supplemented by 32 new implementing acts and a further 11 delegated acts, the preparation of which is still pending.

Timetable

  • The provisions on notified bodies (Articles 35 to 50) have been in force since 26 November 2017.
  • From 26 May 2018 (cooperation between the competent authorities of the Member States and the Commission will begin with a view to the uniform application of the MDR.
  • From 26 May 2019, GS 1, HIBCC and ICCBBA will be considered as designated allocation bodies for UDI.
  • From 26 May 2020 at the earliest or six months after the announcement of the full functioning of Eudamed, the regulations that are inseparably linked to Eudamed and the UDI database will apply. The companies will then have 18 months to register their products in Eudamed.
  • After May 2024, there will be no more valid certificates under old law. Then the extended “sales regulation” will end.

Significant changes by the MDR\

  • Consultation procedure for medical devices containing medicinal products, human and animal tissues and devices ingested and systemically distributed in the body.
  • New rules for market surveillance with shorter reporting deadlines.
  • Additional reports and plans: Post Market Surveillance Plan/Report (PMS), Post Market Clinical Follow-up Report (PMCF), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP).
  • Significantly higher requirements for the generation of clinical data, for example in clinical evaluation: more difficult equivalence analysis; reference to comparative raw data only with the consent of the competitor; higher requirements for the “clinical evaluator”; clinical trials become a must for implants and Class III products.
  • Gradual introduction of UDI labelling.
  • Higher classification of certain material and surgically invasive medical devices.
  • Extension of the scope to include certain non-medical products (MDR, Annex XVI).

Small and medium-sized enterprises (SMEs) express concern that they may receive subordinated treatment because of their lower buying power. Due to lower personnel capacities and financing possibilities, small and medium-sized enterprises are also likely to be affected by the comprehensive new clinical requirements and the extensive documentation and reporting obligations.