Petra, any entity in the EU supply chain between the EU manufacturer/EU importer and the end user (in your case the clinical trial site) that furthers the supply of CE marked medical devices (i.e., is 'making available on the market' the devices concerned), whether for financial recompense or free of charge, becomes, de facto, a Distributor, as defined by the MDR/IVDR, and must therefore comply with the requirements of MDR/IVDR Article 14.
Of course, different requirements apply if the devices are not yet CE marked.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 26-Oct-2021 06:06
From: Petra Rathje
Subject: MDR/IVDR Importer, Distributor, Customer
Dear All,
many thanks for the valuable information on MDR/IVDR topics shared recently. I am still a bit confused when it comes to distributor and customer. For example, when working together as an organization with a service provider / supplier company to support our global pharmaceutical clinical trials. This company providing CE marked ancillary supplies, e.g. medical equipment, ECG machine, etc used in pharmaceutical clinical trials. This supplier company would not be considered as distributor according to EU MDR/IVDR?
Thank you so much in advance for shedding some light on this topic.
Kind regards,
Petra
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Petra R.
Frankfurt
Germany
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