MDR and harmonisation
So far, there has been no harmonisation between standards and the Medical Devices Regulation 2017/745 (MDR). We had already addressed this in our article Basic knowledge on harmonised standards.
Since October 2020, there has already been a "standardisation request" from the European Commission, which lists standards that could be harmonised under the MDR or IVDR.
Anyone who has been involved in the regulatory aspects of medical devices in the past will agree that harmonisation of standards is a fine thing. One can simply pull a harmonised standard out of the drawer, briefly look in the "Annex Zx" to see to what extent the standard is suitable for fulfilling the respective essential requirements and the standard specifications, and thus show that one fulfils the corresponding essential requirements of the respective European directive or regulation (summarised as "presumption of conformity").
However, this is likely to take some time, as the deadline for the implementation of the standardisation request is 27 May 2024.
Simply using the existing standards, which were already harmonised under the Medical Devices Directive 93/42/EEC, is not possible either, because unfortunately there is the following sentence in the Official Journal of the European Union of 25 March 2020:
"The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745. “
So, what does that mean now?
We received a statement from a Notified Body that points in a different direction: "Consideration would need to be given to the IEC/ISO/EN standards used, demonstrating that the respective standard is suitable to cover the relevant General Safety and Performance Requirements of the MDR. “
Should we now each carve our own "Annex Zx" for each standard used?
And which editions of the standard should be used? What if the previously harmonised EN standard has been outdated for years and the newer ISO or IEC standard gives you better solutions?
The first point of the GSPRs says:
" Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. “
In principle, one can assume that a standardisation body that took the trouble to create a standard really wanted to represent an acceptable state of the art.
The inclined user of a harmonised standard also knows that the standards cannot represent everything that is feasible as already shown, but that they do represent a solid state of affairs.
Actually, so-called "Common Specifications" should provide more clarity. Standards are not laws, and volunteers must always be found to do this work for the general public. Therefore, standardisation as well as harmonisation are mostly a long-term task.
But the Commission's Common Specifications (CS) are also not really progressing: as of December 2020, there is no more than one CS - really not very encouraging for manufacturers and other economic actors who are supposed to implement the MDR from May 2021.
At least there are already some MDCG documents, which can provide some clarity; we already reported on these.
Are you looking for a way out of the standards maze? As a competent partner, we are happy to support you and take you by the hand.
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