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QMS and certification requirements for importers and distributors (Article 16)

Giovanni Di Rienzo
Nadira Salah, PhD

We discussed and speculated about this topic in a blog earlier this year but now we have the official confirmation: if you are an importer or a distributor, and you translate any part of the labeling or change the packaging of a device, your life will be much harder under the MDR jurisdiction.

On the 20th of August 2021, the MDCG 2021-23 guidance was published and it confirmed all our worst expectations.

This guidance document is formally intended for notified bodies and provides guidance on certification activities outlined in article 16(4) but it also includes a lot of useful information for importers and distributors involved in re-labelling and repackaging activities per article 16(2).

What are the requirements then for those economic operators? They  must have a QMS in place which includes procedures to ensure accurate translation of labelling, preservation of original conditions of the device, and the quality of the repackaged devices. The QMS must also address the contractual arrangements between the importers/distributors and the legal manufacturer to ensure compliance to the requirements in article 16.

But this is not the end. This QMS has to be certified by a Notified Body with a suitable scope and the guidance document confirms that the “Article 16 QMS” certificate is NOT an ISO 13485/9001 certificate or a CE certificate. It is a full-blown Notified Body certificate requiring on site initial assessment audits, surveillance audits (although with some room for maneuver) and re-certification audits (at least every 5 years).

MDCG 2021-23 describes in some details the minimum required content of the certificate and the requirements for the audits carried out by Notified Bodies; how changes should be handled and how surveillance activities should be conducted.

What is important to notice is that Notified Bodies will not be allowed to issue “article 16” certificates for any device but they will be limited to those that falls within their scope of designation for “traditional” CE certificates. So if you are an importer re-packaging/labeling a wide range of devices you might require more than one Notified Body (probably not a practical solution) or a Notified Body with a wide scope of designation (probably not that easy to find).

It is very clear the intent is to reduce to a minimum those practices; or to bring them to a high level of compliance. This might be on paper a valuable goal but a couple of questions arise. First of all, will this be another move hindering the supply chain of medical devices in Europe? How many importers/distributors will cease activities as a consequence of this, and what will be the impact on the supply of devices?

The other question is related to Notified Bodies. They will probably embrace this service as it constitutes a good additional business opportunity, however will they be able to cope with the extra-workload while they are already seriously stretched for capacity for the traditional CE and ISO 13485 services?

And a third and practical question is about timelines. The MDR is now fully applicable, so from when do importers/distributors need an “article 16” certificate? It should be an already applicable requirement but how could you fulfill it when Notified Bodies are not yet offering the service? There is no response to this question in MDCG 2021-23 but an FAQ document is expected to be published soon and hopefully it will address some of these practical issues. Nevertheless our advice is to not wait for the FAQ document and start setting up your QMS and exploring options with Notified Bodies. It might not be easy find an available one and, once you have found it, obtaining a certificate might be a process longer than you think.

If you are an importer or distributor involved in re-packaging/labelling buckle up because the road ahead will be bumpy. And if you need support to implement your QMS, to find and liaise with a Notified Body or to prepare your audit, please get in touch with us at info@qservegroup.com. We will be more than happy to help you navigate the stormy waters. 

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