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Checklist medical devices distributor (MDR 2017/745)

Are you a distributor?

Start by checking whether you’re considered a distributor under this new regulation. According to the MDR (2017/745) a distributor is defined as follows: “Any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market, up until the point of putting it into service”. If you’re a distributor of medical devices, you must comply with article 14 ‘General obligations of distributors’. This means:

1. It’s up to you to verify that a CE mark is present on the medical device;
2. The EU Declaration of Conformity must be drawn up before a medical device is made available on the market;
3. The instructions for use and labelling must be provided with the medical device and written in the official language(s) of the countries where the medical device is sold;
4. You must verify whether a UDI (Unique Device Identification) has been assigned by the legal manufacturer;
5. You are obliged to inform the competent authority if a device presents a serious risk, or if you (suspect) a falsified medical device;
6. Your company must ensure that the storage and/or transport conditions comply with the conditions set by the legal manufacturer;
7. Last, but not least, distributors are required to register complaints, non-conforming medical devices and recalls.

To meet the above-mentioned requirements, it is well worth implementing a Quality Management System. ISO 13485:2016 is a widely used standard, however, it is not mandatory to have a certified Quality Management System.

Based in Belgium?

If you’re a distributor and located in Belgium, it’s recommended to register your company on the web portal of the Federal Agency for Medicines and Health Products (FAMHP). It’s not obligatory, however, this facilitates direct and faster communication with FAMHP. Furthermore, inspection information will be directly added in the web portal. It’s free to register!

FAMHP also provides a handy document describing guidelines for good distribution practices targeting distributors of medical devices (in Dutch: Distribution NL (fgov.be) and in French: Distribution FR (fgov.be)). A must read!

Also an importer or need for an authorized representative?

Check out the full range of activities performed by your company. If you are also considered an importer under the new regulation (i.e., “any natural or legal person established within the Union that places a device from a third country on the Union market”), your company will also need to comply with article 13 ‘General obligations of importers’. If your medical devices are manufactured outside the European Union, you’ll need to appoint an authorized representative. Articles 11 and 12 in the Medical Device Regulation provide the details.