The obligations of distributors of medical devices are laid down in national laws, for example, under the obligations of economic operators and the operator, and in Regulations (EU) 2017/745 and (EU) 2017/746 (Article 14).
The obligations of a distributor are set out in Article 14 of Regulation (EU) 2017/745 and (EU) 2017/746.
Before making a device available on the market, distributors shall verify that
- the device has been CE marked;
- the EU declaration of conformity of the device has been drawn up;
- the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
- for imported devices, the importer has complied with the requirements set out in Article 13(3);
- where applicable, a UDI has been assigned by the manufacturer.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer.
Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the national competent authority.
Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.
Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
With regard to IVD devices, the operator’s obligations are set out in sections 17 and 18 of the national Act (629/2010).
- The operator shall comply with the information and instructions provided by the manufacturer on the transportation, storage, installation, servicing and other handling of the medical device.
- The operator shall ensure that, when handing over the medical device to the end user, the device is in the condition in which the manufacturer intended the device to be used. A device handed over to an end user other than a professional user shall, where necessary, be properly serviced before it is handed over.
- The operator shall notify the manufacturer or authorised representative of any adverse incidents it has become aware of that have been confirmed, or are suspected of, having resulted from a defect or shortcoming in the device.
- Provisions on the obligation to notify are laid down in section 18 of the Act. Read more about the obligations to notify concerning different operators.
However, in the case of a device placed on the market under the IVD Regulation, the requirements of the IVD Regulation shall also apply to operators.
In other words, the distributor/operator may not, without the manufacturer's permission:
- change the intended purpose of the device
- prepare its own user instructions
- translate the user instructions
- change the packaging, for example by re-labelling it
- change the package size by, for example, selling package sizes smaller than the manufacturer's original packaging
- use its own brand in the product; for example, the “manufactured for” clause is not allowed, the manufacturer must be clearly indicated.
See Article 16 of the Regulations for more information on repackaging and making of translations and MDCG 2021-26 Questions and Answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746