Compliance with the “Essential Requirements” (ERs) is the key element for establishing conformity with the Medical Device Directive (MDD, 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD, 90/385/EEC), likewise is compliance with the “General Safety and Performance Requirements” (GSPRs) in establishing conformity with the published Medical Device Regulation – EU Regulation 2017/745 (MDR). The GSPRs are detailed in Annex I of the MDR and are structured in three chapters.

– Chapter I: General requirements
– Chapter II: Requirements regarding design and manufacture
– Chapter III: Requirements regarding the information supplied with the device

There are 23 GSPRs in the MDR, whereas there are 13 ERs in the MDD and 16 ERs in the AIMDD. The overall text and requirements are enhanced while the scope and topics of the MDR are consistent overall with the ERs of the MDD and AIMD with a few exceptions.

  • Some numbering and organizational changes and some additional requirements because of merging of MDD with AIMDD
  • Overall similar topics and content (some title changes: i.e. construction  manufacturing)
  • Expanded requirements (mainly Risk and Labelling)
  • New areas of emphasis (mainly from standards and industry guidance)
  • Many “state of the art” requirements from harmonised standards have been incorporated directly into the Regulation’s GSPRs.
  • Some topics move out of the GSPR list into Articles / Annexes (Clinical Evaluation, Medicinal Consultation)

o E.g. the requirements for clinical evaluation are now described in Chapter VI: Clinical evaluation and clinical investigations (articles 49-59, Annexes XIII and XIV) of the MDR

  • Some new topics introduced (devices without medical purpose, requirements for devices used by a lay person, etc.)

The areas in Annex I of the MDR considered to have the highest impact to the industry are:

  • medicinal substances (and substances absorbed or locally dispersed)
  • devices incorporating materials of biological origin
  • substances of concern
  • labelling requirements
  • emphasis on cybersecurity for electronic programmable systems (devices that incorporate electronic programmable systems and software that are devices in themselves)

While this blog focuses on Annex I of the MDR, we have to consider that Annex II, clause 4 of the MDR is asking for a documentation that shall contain information to demonstrate conformity to the general safety and performance requirements from Annex I that are applicable to the device taking into account its intended purpose. This shall also include justification, validation and verification of the solutions adopted to meet those requirements. Further on Annex II, clause 4 of the MDR is giving more information what has to be included to demonstrate conformity with Annex I of the MDR.

The slides for you to download are intended to provide you with more details regarding the “General Safety and Performance Requirements” (GSPRs) as detailed in Annex I of the MDR. The presentation does not purport to be complete and I also recommend to keep track of ongoing discussions and monitoring of publications.

Take advantage of our experience, which we are constantly able to expand through our work, by getting in contact with us to discuss your challenges around working towards compliance with the “GSPRs”. We are sure to be able to support you with a solution that suits your needs specifically.

by Urs Widmer, Senior Consultant, confinis ag

Visit the confinis blog post page for more information regarding MDR implementation.