The MHRA has published the draft Statutory Instrument that, when finalised, will replace the current UK Medical Device Regulations, and despite the publication of multiple new or updated MHRA guidance documents on 26 February 2019, confusion remains over the definitions and roles of the UK responsible person and the importer, should the manufacturer be located outside of the UK.
Although the words ‘UK responsible person’ have been substituted for ‘Authorised Representative’ in a large number of places where the draft regulation text is similar to the MDR, the definition of UK responsible person in the draft reg reads as follows:
““UK responsible person” means a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.”
The draft then goes on to explain that (emphasis added):
“Where there is no manufacturer established in the United Kingdom, the person placing the product on the market is to be regarded as the UK responsible person.”
It then backs up this explanation by adding:
“No person may place a relevant device on the market unless that person . . . if they are not the manufacturer of the relevant device, provides the Secretary of State with written evidence that they have the manufacturer’s authority to place the relevant device on the market. Where a person provides the Secretary of State with the written evidence required . . . that person is to be regarded as the UK responsible person.”
Under the MDR and the EU ‘Blue Guide’, only a manufacturer or an importer can place devices on the market, and this is reinforced in the draft reg by this wording:
“Importers must only place devices on the market which are in conformity with this Part.”
The Reg also confirms the accepted role of distributors with regard to advancing devices through the supply chain by stating:
“When making a device available on the market, distributors must, in the context of their activities, comply with the requirements of this Part.”
The distinction between UK responsible person and importer is also addressed in another new guidance from MHRA titled ‘Regulating medical devices in the event of a no deal scenario’, also published on 26 February 2019. In this document there are two sections, one headed ‘UK Responsible Person’, and the other headed ‘Importers’. Interestingly, ‘importer’ is defined as “any person established within the United Kingdom that places a device from a country outside the United Kingdom on the market”. This again reinforces the automatic designation of the importer as the UK responsible person under the draft reg. The section covering the UK responsible person does not mention anywhere that this role includes ‘placing devices on the market’, again reinforcing the concept that the importer must be the UK responsible person, because he is the only person capable of placing a device on the market.
So up until this point, it appears that the importer, being responsible for placing devices on the market, automatically becomes the UK responsible person, and so must act “on behalf of a manufacturer . . . in relation to specified tasks with regard to the manufacturer’s obligations“.
The draft reg also states:
“A UK responsible person —
(a) may be proceeded against as a person placing the device on the market for the purposes of these regulations;
(b) in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.”
While part (a) of this makes sense – because the person placing the device on the market is the importer, who, according to the reg, must also be the UK responsible person, part (b) does not make sense, because the importer is not responsible for making devices available on the market, unless he is also a distributor, in which case he has a dual role, and must therefore take responsibility for both activities.
Under the MDR, the roles of Authorised Representative, importer and distributor are distinct and separate, allowing the Authorised Representative to be independent from the importer and distributor. However, if under the draft UK reg, the UK responsible person is able to be independent from the importer and distributor, how can he be responsible for one or both of placing devices on the market and making devices available on the market, if he is not in the supply chain, especially bearing in mind the words of the draft reg which require that if: “they have the manufacturer’s authority to place the relevant device on the market . . . that person is to be regarded as the UK responsible person“. If this is the correct interpretation of the draft reg, then by definition, only the importer can be the UK responsible person.
Unless this changes in the final regulation, it would appear that the best strategy for non-UK manufacturers would be to designate the importer as the UK responsible person to avoid any future confusion.