As defined in the UK MDR 2019 law, a UK responsible person is an individual who is deployed and established in the UK to carry out all administrative and legal formalities on behalf of a manufacturing company established beyond the UK to fulfill the responsibilities of producer under the regulations for getting the UKCA mark.

To initiate marketing on the Great Britain market containing England, Scotland, and Wales it is compulsory to get registered with MHRA. Those who are manufacturing medical devices based in other cities beyond the UK need to appoint a legal person or company recognized in the UK to get registration and get started with the necessary UKCA marking.

There by the manufacturer or their designated UK Responsible person will be legally allowed to put the device in the UK Market. Noteworthy that the name, as well as address of the UK Responsible Person, will be required to affix labeling of the product and the marking to ensure adherence to UKCA.

There after the certified devices as per the rule of MDD/IVDD will continue to be sold in UK with the changed labelling. A documentary proof needs to be displayed on the agreement between the manufacturing company and UK responsible person. The UK responsible person’s agreement needs to be presented to letter head of the company with the signature of both the parties under the agreement.

It is worth noting that the medical device and IVD medical device regulations have also introduced the necessity of registering medical devices in the database of the European system. The objective of EUDAMED registration is to ensure the effective tractability of the device in the widespread and complex supply chain.

Responsibilities of UK Responsible person

UK responsible person needs to carry a copy of the detailed technical documentation in addition to the declaration of adherence and the certification should include amendments and supplements for necessary inspection as accomplished by the MHRA.

The individual needs to make sure that declaration of conformism and mechanical documentation with an applicable conformity assessment process has to be performed by the manufacturing company to obtain the UKCA Marking.

He needs to furnish a MHRA with all required documentation required to demonstrate adherence to the standard that the device requires. He will also be responsible for collaborating with MHRA to improve the legal issues related to the device.

He will also immediately inform the manufacturer about complaints and reports from healthcare professionals, patients, and users about suspected incidents related to a device for which they have been designated.

The person will also be terminated by the manufacturer if he does nothing that contradicts the regulation and needs to inform MHRA as well as the notified body in regard to the termination.

He will also need to perform specified tasks pertaining to the obligation of the manufacturing company having registration with MHRA prior to placing the device in the UK market.

View Source : https://www.freepressreleasedb.com/pr/What-You-Need-To-Know-About-UKPR-Before-Marketing-Your-Medical-Device-in-UK-PR312258/