ONE of the many questions we are asked when we run our courses is: What are the regulations around product competency when medical device companies sell through a distribution firm?
Well, the answer is that it’s a bit of a grey area. However, as is frequently the case with medical products and services, compliance is key.
The manufacturer should ensure their distributors are trained and competent on their products.
The EU Medical Device Regulation does detail obligations for the manufacturers for “economic operators” in the supply chain – and these include distributors and importers.
The two sets of legislation that apply are Product Liability and the EU MDR.
From a liability perspective, a manufacturer should satisfy themselves that distributors and their staff are trained to the same level as the manufacturers’ own employees, in terms of competency.
This ensures that end-users are capable of operating the equipment as intended and safely, thus presenting minimal risk to the patient as detailed in the Instructions For Use.
The Distributors should also ensure they have the necessary resources for on-going training of existing staff and the support of new staff.
The definition of “distributors” is: any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market up until the point of putting into service.
However, the question has to be asked: “Are they wholly owned distributors or are they completely independent third parties?”
In the case of the wholly owned distributor (an entity owned by the same company as the manufacturing organisation) their staff would need to be trained to exactly the same standard as the company’s direct sales individuals. That means completing a Hospital Theatre (Operating Room) Access training programme and Product Training.
But should a third-party organisation (one that has no link to the manufacturer) be treated any differently?
Are their responsibilities so significantly different from those of the manufacturer that an alternative level of training should be given?
Some might suggest that an abridged version of our Theatre Access course would suffice – or maybe even no training at all.
This situation could make it very difficult for the manufacturer to evidence compliance with the EU MDR. Perhaps a deeper grey area?