Responsible Person Agreement
Documentary evidence in the form of a contract between the manufacturer and the person responsible for the United Kingdom must be signed in order to support its position. This evidence must take the form of a head title (letter of designation) or a signed contract indicating the name and address of the company for both the foreign producer and the person responsible for the United Kingdom. A responsible person in the United Kingdom must be headquartered in the United Kingdom „in which the meaning of a document relating to the marketing of the device in question will be effective.” This address is used for official communications, regulation 60 of the British MDR 2002 (amended by the British MDR in 2019) stipulates that a person responsible in the United Kingdom can act against the device as a person who puts the device on the market within the meaning of the regulations. Given that the 2002 UK MDR (as amended by the UK MDR 2019) is a safety regulation within the meaning of the Consumer Protection Act, it is possible that a person responsible for the United Kingdom will be brought against it under the Regulations or consumer protection act of 1987 if it fails to comply with one of its obligations. It is also possible that an individual may be held responsible. According to the UK MDR, the person responsible is „a UK-based person who acts on behalf of a producer based outside the UK with respect to certain tasks related to the manufacturer`s obligations under the manufacturer`s rules” in accordance with UK MDR 2019. Manufacturers need to determine if there are managers after they go on the market. These responsibilities should be clearly defined in the interim mandate between the manufacturer and the person responsible for the United Kingdom. The manufacturer must continue to fulfil all its obligations, regardless of the responsibility of the person responsible for the United Kingdom. Our senior consultants are licensed by MHRA as head of the UK wholesale drug contract and are also registered as pharmacists at GPhC. It is rare for new startups and organizations to take their first steps in the wholesale drug trade to employ a responsible company-based person because of the high cost and/or lack of experience.
Ultimately, the onus is on the licensee, as a contract giver, to demonstrate that the selected advisor is fit to play the role of the PC in its business model and that it must be defined in an appropriate contract. This contract should mention the PC in the license; It is not enough to mention the board.