March 21, 2023

EU MDR Notified Body Demanding Use of Harmonized Standards

Your notified body seems to be employing a classic infamous misuse of harmonized standards for the MDD and/or EU MDR.  I generally advise our clients to respectfully, carefully, and legislatively, push back on such misuse.  But without seeing the full details of the nonconformity and of your particular case, it is not possible to say for sure whether such push back is for certain appropriate for your scenario.

In general, much has been said, for example here, regarding use of harmonized vs. non-harmonized standards. So I won’t say much more about that in this current post unless further questions are raised.  See also MDCG 2021-5 for the latest-and-greatest interpretations about this, such as the MDCG’s ultimate summation that, “...in general the use of harmonized standards is voluntary.”

The real legislative requirement (see for example in my prior post and in MDCG 2021-5) is for us to take into account the generally acknowledged state of the art.  That obligation is generally the same regardless of whether we are talking about the MDD or the EU MDR. Accordingly, any conformity solution should be anchored by that endeavor, especially in times like these where, so often, an updated harmonized standard isn’t yet available for a given EU MDR GSPR.  Our ultimate legislative requirement is to show conformity with the applicable GSPR, not with a harmonized standard(s).  Yet notified bodies still try to assert that harmonized standards are required.  They do that either because the notified body doesn’t understand the legislation or because it makes their job easier.

On that note, while it might be helpful to provide a notified body a gap analysis between your conformity solution and a harmonized standard, it remains true that lack of such a gap assessment is not a valid reason for a nonconformity.  In general, the most that is appropriate for a notified body to do is request such a gap analysis as a matter of convenience for the notified body (notwithstanding the possibility of an overreaching clause in your business contract with the notified body).  Such a gap assessment is not legislatively required and thus shouldn’t be lodged as a technical documentation nonconformity; instead, the legislation leaves us wide latitude in how we show conformity.

Another scenario I’ve heard about is a notified body’s request for a comparison between the GSPR conformity solution applied compared to an MDD harmonized standard.  Specifically, EU MDR conformity isn’t based on evolutionary comparison, or any other comparison, to the MDD, its Essential Requirements (ER), or standards that were harmonized for use with the MDD.  Instead, EU MDR conformity is based on showing conformity to the EU MDR and its GSPR.  Indeed, the MDD ER or harmonized standards aren’t required to be raised at all in an EU MDR technical documentation review unless the manufacturer has formally mandated itself to such an approach, like via a corresponding QMS document or regulatory strategy.

These are some dynamic variables that might play into your particular scenario.  You might want to consider seeking some expert assistance to be sure your next steps are the right ones.  In any event, hopefully the legislative bottom lines noted in this post will be helpful for you if you are formulating a response to such notified body gestures.