Services

UK Responsible Person

Services

The UK Medical Devices (Amendment etc.) (EU Exit) Regulations has introduced a new economic operator in the UK market, namely the “UK Responsible Person” (UKRP). The UKRP has been defined as a person established in any part of 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.

According to the current version of the UK MDR a manufacturer shall designate only one UK Responsible Person.

Device/Product Registration

The UK Responsible Person will take on the responsibility for the manufacturer to register the devices with the electronic system set-up by the Medicine and Healthcare Products Regulatory Agency ( MHRA ) and will act as the point of contact for that manufacturer. The registration with the MHRA must be reviewed and renewed one year after the anniversary date and every two years subsequently.
For full details ……

https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

As of 1st January 2021, it is a UK government requirement that all medical devices placed on the Great Britain market are registered with the MHRA. Under the terms of the Northern Ireland Protocol, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain; however, there is a requirement, in most cases, to register these devices with the MHRA.

For full details concerning these requirements see the UK government website by clicking here

Applicable Regulations

Great Britain: In Great Britain, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA.

Northern Ireland: Unlike in Great Britain, the EU Medical Device Regulations (2017/745) and the in vitro Diagnostic Medical Device Regulations (2017/746) will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline.

Certificate of Sales Services

A CFS, as a self-declaration issued by the UK RP, is a valid document accepted by several countries. However, some authorities require the CFS to be issued by the national Competent Authority or a relevant organisation, which could be a Government Department, a trade association or a Chamber of Commerce. As Vera Global , we will assist the non UK manufacturers to order and receive Certificate of Free Sales.

For details regarding Certificate of Free Sales see the UK Governmebt website by clicking here

https://www.gov.uk/guidance/export-medical-devices-special-rules

UKCA MArking and Regulatory Consultancy

What is UKCA marking?

Once the UK left the European Union via Brexit, the MHRA developed its own conformity assessment process: UKCA marking. Like European CE marking, the UKCA marking requires that devices (other than lowest risk, which are self-certified), obtain a conformity assessment certificate issued by an accredited body. The UK designated their own conformity assessment bodies, who are authorized to issue UKCA marking certificates. These are called Approved Bodies and are similar in concept to a Notified Body. The list of UK approved bodies can be found here.

The UK left the EU before the Medical Devices Regulation (MDR)/In Vitro Diagnostic Devices Regulation (IVDR) dates of application. Therefore, the UK medical device regulation is currently based on the old Directives – MDD/AIMD/IVDD. As a result, an MDD/IVDD compliant technical documentation file in general meets UKCA marking requirements, except for gaps such as appointing a UK Responsible Person instead of an EU Authorized Representative, and of course, referencing the UK legislation throughout instead of the EU Directives/Regulations. However, it is not so simple. The MHRA is in the process of updating its legislation and the new regulation is expected to go into effect in 2023. Many of the proposed revisions appear to align with the MDR/IVDR, including appointment of a Quality Person (similar to an EU Person Responsible for Regulatory Compliance (PRRC)); requirement for liability insurance; up-classification of certain devices; and overall increased scrutiny.

Northern Ireland will continue to require CE marking. Even though Northern Ireland is part of the UK and has therefore left the European Union, it will not implement or recognize UKCA marking.

When is the deadline to UKCA mark medical devices & IVDs?

UKCA Marking Symbol.

• Successfully penetrate the UK marketplace;
• Ensure compliant technical documentation;
• Regularly updating the company abaout UKCA marking process and transition.
• Contacting and working with the Notified Bodies to carry out activities related to the UKCA marking process
• Evaluate UK market claims;
• With UK labelling and translations;
• Remain updated on legislative, economic and political matters that may influence your product compliance;
• By providing support in determining an effective UK market strategy.