MDR 2017/745, which was enforced on May 26th, 2021, expands the responsibilities of importers and distributors. This article will examine the revised responsibilities of the importer and the distributor under the new regulation.
What is an Importer under MDR 2017/745?
Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service.
Responsibilities of the Importer
- Shall only place devices that conform to MDR on the market.
- Verify that the device is CE-marked.
- Verify that a Declaration of Conformity is available.
- Verify that a manufacturer is identified.
- Verify that an authorised representative has been designated by the manufacturer.
- Verify that the device has all required labelling as per MDR requirements
- Verify that a UDI has been assigned by the manufacturer where applicable.
- Place their name, registered trade name, mark, registered place of business and address details on the associated packaging or in the documentation which accompanies the product.
- Shall ensure all storage and transport conditions comply with the general safety and performance requirements outlined in Annex I and by the associated manufacturer.
- Shall maintain a register of complaints, non-conforming devices, recalls and withdrawals.
- Shall inform the manufacturer or its authorised representative if there is any doubt that the device placed on the market does not comply with MDR.
- Shall liaise with the manufacturer, authorised representative and importer/distributor (where applicable) regarding complaints, non-conforming devices, recalls and withdrawals.
- Shall retain a copy of the EU DoC and a copy of any relevant certificate where applicable
- Shall cooperate with any competent authority request.
What is a Distributor under MDR 2017/745?
Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service.
Responsibilities of the Distributor
- Verify that the device has been CE-marked.
- Verify that the EU Declaration of Conformity is available.
- Verify that the device has all the information provided by the manufacturer.
- Where imported devices are concerned, verify that the importer has complied with Article 13 (General Obligations of Importers).
- Verify that a UDI has been assigned by the manufacturer where applicable.
- Shall ensure all storage and transport conditions comply with the general safety and performance requirements outlined in Annex I and by the associated manufacturer.
- Shall communicate complaints, or reports from healthcare professionals, patients or users about suspected incidents pertaining to a device they have made available to the manufacturer and where applicable the manufacturer’s authorised representative and the importer.
- Shall maintain a record of all complaints, non-conforming devices, recalls and withdrawals.
- Shall keep the manufacturer, the authorised representative informed of all progress associated with complaints, non-conforming devices, recalls and withdrawals and provide them with any information upon request.
- Shall cooperate with any competent authority request.
We Can Help You With Your MDR Issues
Our team is currently working with a wide range of companies and devices, helping them adjust to the new regulations. If you would like us to help your company then get in touch. Contact us by phone on 00353 52 61 76 706 or complete the form on our Contact Us page and we will get back to you straight away.
