Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…

30 March 2019 |


Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 – Interpretation of Article 54(2)b we regulatory geeks just knew we should take a look.

A racy read, a real page-turner it is not. But buried within the dry-as-dust text is an important nugget of information which has real commercial implications.

Put succinctly:

  • Article 54 is the part of the Medical Device Regulation which requires that clinical evidence for certain Class III and Active Implantable (AIMD) devices be referred to expert panels for review.
  • Article 54(2)b sets out exemptions for such referrals where a marketed device is modified, but the design change does not impact the validity of prior clinical evidence.

The problem is – this article is part of the MDR. A requirement that the device be previously legally marketed, strictly interpreted, means that the device should already be approved under the MDR.

But what about a device whose design changes at the same time as a transition from MDD to MDR takes place? This ambiguous wording could be interpreted as requiring the referral of a lot of devices for expert panel review even for relatively minor design changes, swamping the panels with unnecessary work and causing the whole thing to grind to a halt.

As if there weren’t enough challenges already to the implementation of a smooth transition to MDR.

So thankfully, cool heads put their minds to this and concluded that this regulation should be interpreted broadly – and that a modification to a device certified under the MDD should be eligible for the exemption.

So – if you are still following me, and haven’t yet dozed off, you can now retire and sleep easily. This is one less thing to worry about in the MDD-MDR transition.

And we will keep on looking for those devilish little details – it’s what we like to do!

Read the MDCG announcement here (PDF download)

Read the MDR here (also PDF).


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