Is ISO 13485 Required for CE mark?
ISO standards can be expensive, I know. So can the certification towards them.
Auditor fees, cost of nonconformance, the time taken out of the day to day to facilitate the audits. Ever growing costs that recur year on year.
So, comes the question, are they mandatory? MDCG have issued their thoughts - "Choosing to use a standard or not belongs to the manufacturer" - MDCG 2021-5 Rev 1.
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.
They are very clear in specifying 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”.
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 and if you've done things such as reference them in your list of applied standards etc.,
MDCG also go on to specify that if 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 way complex though, 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.
Manufacturers have enough on their plate, never mind trying to reinvent technical standards to avoid buying some copies of ISOs and implementing ISO 13485. Pro tip - I'd recommend https://www.evs.ee/et/ if you're looking for some cheaper standards...fellow consultants will shoot me...
I cover this in more detail in my (occasionally published) newsletter - https://lnkd.in/eKeTqA8T