NEWS FROM MDCG: MDCG 2021-5 Guidance on standardisation for medical devices

The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.
In a commission implementing decision dated 14 April 2021, the Commission calls on the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to revise some 201 existing harmonized standards and draft 27 new standards over the next three years. The two standardization bodies have one month to indicate whether they will accept the request under Regulation (EU) No 1025/2012 and the Commission has asked CEN and CENELEC to submit a joint work program by 28 May 2021.

The contents of this document:

1. EU legislation on medical devices within the “New Approach” and the “New Legislative Framework”

2. The general framework for harmonised European standards:

  • 2.1. Main references
  • 2.2. Voluntary use of standards
  • 2.3. The relationship between harmonised European standards and EU legislation: the “Annex Z”

3. Harmonised European standards in support of the EU legislation on medical devices

  • 3.1. Legal references, European standardisation organisations and standardisation mandates or requests
  • 3.2. Development of harmonised European standards for medical devices and assessment by the HAS consultants
  • 3.3. Publication in the OJEU of references to harmonised European standards to confer presumption of conformity
  • 3.4. International aspects of standardisation
  • 3.5. The concept of “state of the art”, European standardisation and conformity assessment for medical devices

4. Governance structure for standards in the medical devices sector 4.1. The MDCG Subgroup on Standards 4.2. The CEN-Cenelec Advisory Board of Healthcare Standards (ABHS)