The roles of CEN, Cenelec and HAS consultants
Regarding development of hENs for medical devices, these efforts fall either to the European Committee for Standardization (CEN), which covers most types of medical devces, as well as the European Committee for Electrotechnical Standardization (Cenelec), which focuses on medical electrical equipment.
Under the current Directives, European Commissioners submits requests via standardization mandate format either to CEN or Cenelec to develop standards that align with European legislation. Following the MDR and IVDR dates of application, updated standardization requests will be used for the same purpose, but with improved formatting similar to that of Commission Implementing Decisions.
The standardization request process under the MDR and IVDR will undergo regular revision and updating to reflect evolving European as well as international standards development, according to the MDCG.
As European harmonized standards are developed either by CEN or Cenelec, technical experts known as Harmonised Standards (HAS) consultants assess drafting progress to ensure that standards in question accurately and clearly track relevant European legislation; HAS consultants managed by an independent organization per European Commission stipulations. Following their development and drafting, new or revised hENs are published in the OJEU, as well as their associated references.
Regarding “state of the art”
In addition to hENs, the MDCG guidance also covers the issue of “state-of-the-art” standards and concepts as they relate to medical device safety and performance. MDCG distinguishes between compliance and accounting for state-of-the-art considerations, however, when it comes to conformity assessments and certifications.
“Actually, ‘state of the art’ standards do no confer any presumption of conformity if their references are not cited in the OJEU, as harmonised European standards developed by the ESO’s (European Standards Organizations) on the basis of a standardization mandate or request issued by the Commission,” the guidance states, noting once again that Competent Authorities and Notified Bodies have no authorization to require adherence to any standard, including state-of-the-art provisions or components within a particular standard.
European regulators’ approaches to state-of-the-art concepts bears further monitoring, but ahead of the MDR date of application, this additional guidance from MDCG may provide useful clarity on the issue.
Learn more about European MDR compliance at Emergo by UL:
- European MDR preparation and compliance resource center
- European Authorized Representative in-country representation
- Whitepaper: Extended MDR date of application—optimizing your PMS and clinical activities
- Webinar: Europe’s new Medical Devices Regulation (MDR)