Choosing to use a standard or not belongs to the manufacturer - MDCG 2021-5 Rev 1

Are standards mandatory? The age old question. Below, I will attempt to outline some of the key documents and salient points that manufacturers can use.

MDCG have done their best to clarify this paradox that haunts manufacturers, quality managers and regulatory professionals within MDCG 2021-5 Rev 1 Section 2.2 - Voluntary Use of Standards and Section 3.5.

Within Section 2.2 of MDCG 2021-5 Rev 1, MDCG specifies that:

“the use of standards (either harmonised European standards the reference of which is published in the Official Journal of European Union or any other standard) in the medical device sector is and remains voluntary.”

Standardisation Regulation 1025/2012 details this at length within the relevant recitals of that regulation, however, the main thing is that these provisions apply in full to EU legislation on medical devices.

MDCG correctly call out that there are “exceptions to the rule”. This relates to MDR Annex I 23.1 (h) which specifies:

“Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device”.

This essentially is saying that ISO 15223 and ISO 20417 must be used.

If we move to Section 3.5 of MDCG 2021-5 Rev 1, the document further details that:

“it is not possible to impose the use of a specific standard in the conformity assessment of a product, not even on the basis of “compliance with the state of the art”.

It then seems to contradict elements of its own argument and the regulation by specifying the following:

“For conformity assessment procedures requiring its intervention, the notified body must check whether the concerned device complies with the requirements of the regulations on medical devices, and in this sense it must “take into consideration available CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance””

Does this mean Notified Bodies can raise nonconformances against me based upon harmonised standards even if I haven’t applied them?

Yes. Yes, it does - If you have no other way of demonstrating conformity.

Harmonised standards of which have been published in the Official Journal of European Union enable presumption of conformity.

However, provided a manufacturer is able to demonstrate that different or alternative non-harmonised means are adequate to comply with legal requirements applicable to the product using things such as risk assessments, gap analysis or compliance matrices that can be leveraged through the conformity assessment procedures. This is no small feat to do this.

Ultimately, what I hope I’ve proven here is that life is WAY easier using harmonised standards to enable a presumption of conformity to legal requirements as opposed to gap assessments, compliance matrices and other length and complex ways.

P.S - if you’re looking for some cheaper versions of ISO standards for example, check out https://www.evs.ee/et/. Don’t tell anyone though, please…