CHESHAM, UK: The medical device regulation (MDR) brings a raft of additional responsibilities for manufacturers’ quality and regulatory affairs teams. Moreover, they will also need to familiarise themselves with new obligations for other economic operators—such as authorised representatives, importers and distributors. In a recent article for the British Dental Industry Association, Adam Stanley discusses the first set of guidance documents the Medicines and Healthcare products Regulatory Agency (MHRA) has shared for economic operators—in this case, addressing the obligations of distributors under the MDR.
The MDR defines a distributor as “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market, up until the point of putting it into service”. This definition seems generally intuitive; however, the guidance also specifically notes that dental practices supplying devices to patients would be included—a further reminder of the expanded scope of the MDR. According to Stanley, policy and public affairs manager at the British Dental Industry Association, it is essential that distributors familiarise themselves with these requirements, particularly as this is the first time that distributors of medical devices will be regulated by the MHRA. It is vital that companies do not assume that everything will be business as usual and that what was compliant under the old regulatory regime will be sufficient in future.
Some of these requirements already exist under the EU ‘Blue Guide’ on the Implementation of EU Products Rules; however, the MDR builds upon them and makes them legally binding. Before making a device available, the key distributor responsibilities to be aware of under the MDR (Article 14) are:
- checking that the device has received a CE marking and has a declaration of conformity and that the CE certificate is still valid;
- checking that the device is labelled and accompanied by instructions for use where required;
- checking, for imported devices, that the importer’s name and address are included on the device, its packaging or accompanying documentation;
- checking that the unique device identifier has been assigned by the manufacturer, where applicable; and
- complying with the manufacturer’s conditions for storage and transport.
Additionally, MDR responsibilities continue to apply to distributors after the device has been made available. The MHRA guidance explains these obligations in detail, including how, when and whom to inform in the event of non-conformity or suspected incidents related to a device that a distributor has made available. Broadly, these responsibilities consist of ensuring that relevant information is passed on to other points in the supply chain (such as the manufacturer, competent authorities or other economic operators) as required. As such, the regulation enshrines in law a higher level of record-keeping and reporting requirements than companies may have previously been familiar with.
Distributors should also be aware of the situations in which they could assume manufacturer responsibilities. Although not referred to as such in the relevant section of the MDR (Article 16), these are the scenarios known more generally as virtual manufacturing and apply manufacturer obligations when the distributor:
- makes a device available on the market under its own name and the original equipment manufacturer is not identified on the label;
- changes the intended purpose of an existing device; or
- makes any significant change or modification in design, material, chemical composition or energy source of a device.
Some changes by the distributor can be made without assuming manufacturer responsibilities, such as the translation of information provided by the manufacturer and certain changes to outer packaging. However, distributors should make careful reference to the regulation in order to ensure that these changes are permitted and that they have met their obligations, including those under their quality management system, relating to the supply of relevant information about the changes made.
“Any distributor that has not already done so should familiarise themselves with these parts of the MDR as soon as possible,” noted Stanley. “While the requirements are significantly less demanding than those placed on manufacturers, the fact that some of them are appearing for the first time and that distributors will now find themselves directly regulated by the MHRA means that it is essential not to be caught out.”
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