European Regulatory requirements1
DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether:
- the device has the (CE) mark and an EU Declaration of Conformity has been issued;
- the importer’s name is affixed on each device or is in the attached documentation (where applicable);
- the device bears a unique device identifier assigned by the manufacturer (where applicable);
- the device is labelled properly and has instructions for use (IFUs) in an official language of the country in which it will be marketed
In addition, distributors are responsible for:2,3
- ensuring storage and transportation of devices under appropriate conditions as defined by the manufacturer; and
- notifying the manufacturer and competent authorities when they suspect a device has been falsified or presents a serious risk to patient health
These are the facts.
A question for medical device and IVD distributors: How will you ensure compliance?
As the regulatory operations teams working for medical device and IVD manufacturers are struggling to manage the myriad of internal MDR/IVDR data requirements,
- Who in your organisation is managing and supporting all of your economic operators to ensure no disruption to your supply chain and revenue stream?
- Are you assuming your distributors have got it covered as it is their responsibility?
- Can you even link your economic operators to a specific device or even device family?
- How will you exchange the necessary data between yourselves and your disparate distribution chain?
For those of you who cannot confidently answer these questions, I suggest giving me a call.
I can help sort you out.
+44 (0)7384 116106