Let’s say I am a medical device importer or distributor and have just begun to think about how to incorporate MDR Article 14 and applicable EUDAMED requirements into my day-to-day processes, when the regulatory manager at manufacturing company AXV asks me about compliance to MDR Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”.

What? Not only do I have these new MDR obligations as an importer or distributor, but I might even have even more requirements as a manufacturer? But, wait, I’m not a manufacturer!

Yes, an importer or distributor will assume MDR manufacturer obligations for compliance if:

  • Placing the device on the market under their own name (unless a different agreement is reached with the manufacturer)
  • Change the intended purpose of a device already on the market
  • Significantly modify a device already on the market

However, if you attach a local translation of required information or repackage the device without changing its original condition (example sterility) then you are not a manufacturer. Well, I say, great stuff as my facility does not perform any of those activities. Article 16 then continues…..

— At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in the above paragraph shall inform the manufacturer and the competent authority of the member state of the intention to make the relabelled or repackaged available and upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged devices, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate issued by a notified body designated for the type of device, attesting that the quality management system of the distributor or importer complies with the following:

  • Assurance that any translation is accurate and up-to-date
  • Relabeling and repackaging activities are performed adequately to preserve original condition of the device
  • QMS system includes process for corrective actions relating to safety issues

OK, I manage a distribution warehouse, receiving different medical devices from multiple manufacturers, occasionally we shift stock into different packaging as per my end customer’s requirements and maybe add a bit of local language labeling over the original. Do I need to comply with all of these regulations?

The short answer is an emphatic – you need to find out.

The HPRA of Ireland has published a very comprehensive guide, specifically for medical device distributors: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13

A special note to those individuals working in medical device industry. You need to contact everyone in your European supply chain NOW.

Help them navigate through the quagmire of regulations, certifications and guidances. They do not have the experience with these activities, you have a regulatory team skilled in legislation interpretation and impact communications.

The success or failure of your European medical device supply chain ultimately rests with you, the manufacturer.

Kim.Young@instem.com

K Young