Last week, MDCG 2021-5 Guidance on standardization for medical devices was published. There is a great need for this guidance because for the MDR and IVDR no harmonized standards are yet available while at the same time in the regulations it is mentioned that harmonized standards should be used as a means for manufacturers to demonstrate conformity with the General Safety and Performance Requirements (GSPR). In the guidance document it is mentioned explicitly that the use of harmonized standards is voluntary, which is clearly stated in the Standardisation Regulation (EU) 1025/2012 that is ruling the whole system. The only exception is in case of the use of symbols and identification colours where harmonized standards shall be used when they are available.
The statement that the guidance document makes is that the decision to use a standard or not belongs to the manufacturer and that the use of specific standards cannot be imposed. This means that competent authorities or Notified Bodies cannot prescribe the use of a certain standard. In order to place a medical device on the EU market, the medical device must comply with the health, safety and performance requirements of the applicable legislation which in case of the MDR or IVDR is covered by meeting the requirements of the GSPR.
If the use of a standard is voluntary, how then do you choose which standards to use? The guidance document elaborates on ‘Annex Z’ that describes the relationship between harmonized European standards and EU legislation. In general, this annex includes one or more tables listing the clauses of the standard and their correspondence with the legal requirements which can be very helpful when checking if and where all requirements are fulfilled by following the standard, assuring legal certainty to manufacturers. For the MDR and IVDR manufacturers, this legal certainty is not available due to the lack of harmonized standards. Additionally, in a lot of the standards that where harmonized under the MDD and IVDD newer versions have been published. How do the references in the MDR and IVDR to “take into account the generally acknowledged state of the art” then need to be explained? Don’t they require the manufacturer to use the most recent version of a standard? The guidance document explains that ‘state of the art’ is not a legally defined concept and ‘taking into account’ is different from ‘compliance’.
The conclusion on all of this is that it is not possible to impose the use of a specific standard in the conformity assessment of a product. Choosing to use a standard or not, as appropriate and applicable, belongs to the manufacturer, within its overall and ultimate responsibility on the legal compliance of products intended to be placed on the EU market. What then can be expected from the manufacturer in the execution of his responsibility is a justification of the choices made with regards to the used standards.