The Medical Device Regulations for Distributors will come into force mid-May 2021 (after being postponed by 1 year due to Covid-19). Through this regulation, the European Union has streamlined the various fragments of regulations of directives and regulations that previously existing. The idea behind this regulation is to define the level of standard for the quality and safety that is required for medical devices to be made available for sale in Europe.
A distributor refers to any company, natural or legal person in the supply chain, other than the manufacturer and importer (anyone who places a device from a third country on the Union market), that makes a device available on the market, up until the point of putting the product into service.
The activities of a distributor, for the purpose of this regulation include:
- acquisition of medical devices
- holding of medical devices
- and supplying of medical devices
Any product which combines a medicinal product or a substance and a medical device are regulated under this regulation. Should a device have both a medical and non-medical function, it should fulfil both the requirements of devices with and without an intended medical purpose.
Medical Device Regulations for Distributors
Within the Regulation (EU) 2017/745 of the European Parliament on medical devices, Article 14 sets out the general obligations of distributors for medical devices.
- Distributors must act with due care in relation to the requirements applicable
- Before placing a device on the market, distributors shall confirm that all the following requirements are met:
- All devices should have a CE Marketing to indicate that they conform to this regulation. In turn, this would mean that these medical devices can be sold freely within the European Union.
- The device has the information supplied by the manufacturer (as per article 10(11) of these regulations
- For imported devices, the importer has complied with the requirements set out in Article 13(3)
- Where applicable, a UDI (Unique Identification system – covered in Article 27 of the medical device regulations)
3. Distributors must make sure that they ensure safe handling of the product. This is done by ensuring that storage or transport conditions comply with the conditions set by the manufacturer. Read more about Good Distribution Practice (GDP) here.
4. Where a distributor has a reason to believe that a device is not in conformity with these regulations, the product in question should not be made available on the market. Moreover, it shall inform the manufacturer, the authorised representative, or the importer, of such deficiencies.
5. Whenever a complaint is received from healthcare professions, patients, or users, about a specific product, it shall inform the manufacturer, the authorised representative, or the importer, of such deficiencies. Moreover, a register of complaints must be kept that includes information on non-conforming devices, and of recalls and withdrawals.
6. Naturally, distributors must provide any information or documentation that is required by the competent authority as deemed necessary.
Should the distributor do any of the following, there are further requirements:
- do any translation of the information supplied by the manufacturer
- change the outer packaging of a device
In such a case, the distributor shall indicate on the device, or if impracticable on its packaging or in a document accompanying the device, the following:
- the activities carried out
- registered trade name/mark
- registered place of business
- address at which it can be contacted
In this case, distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date. Just like the building maintenance report for ISO 27001 Certification, the requirements for the medical device regulation are very specific.
Why is ISO Certification important? An ISO Certification is practically required for any company following the Medical Device Regulations for Distributors. This might be required either by the suppliers or by the client. Whatever the case, the benefits of ISO 9001 Certification will be instantly visible for any distributor of medical devices.