Why Is Appointing UK Responsible Person Has Been Mandatory To Market Medical Devices For Foreign Manufactures outside The UK?
After the exit of Britain from EU, the earlier term of EU authorized representative has been replaced by The UK responsible person (UKRP). As stated in UK MDR 2019 and its updated regulation by UK MDR 2002 a UK responsible person is one who functions as a representative of an overseas manufacturer that operates outside of the UK in order to execute the responsibilities of the manufacturing company under its regulations.
Precisely, henceforth foreign manufacturers of medical devices will be permitted to promote their product on the UK market only by a local office of the manufacturer or by an approved UKRP.
The manufacturer needs to make an official agreement with The UK Responsible Person on appointing the professional as evidence to prove the same to the MERA authorities. The agreement must be signed between the two parties. This mutually signed contract or letter of designation should comprise the name and address of both the UKRP and the manufacturer.
The document should specify the role and authority of the UK Responsible Person for functioning with an official agreement on the behalf of the foreign manufacturer. In addition, it should declare that the medical devices likely to be launched on the UK market are designed to maintain the standard of its applicable laws.
On September 2019, the Medicines, and Health Care items Regulatory Agency or MHRA has published completely new guidelines pertaining to the responsibilities and functions in order to regulate medical device marketing followed by Brexit.
Why Consider Appointing ALS International Ltd as Your Dependable UKRP?
We at, ALS have a long-term experience and awareness about the latest rules and regulations of MHRA which will be at immense help for you to market your product in the UK market backed by our dedicated UK Responsible Person sticking to the law. Equipped with a pool of knowledgeable professionals and representatives in various countries, we offer comprehensive services and solutions to foreign medical device product manufacturers worldwide since 2020.
- With a team of veteran consultants, regulatory professionals as well as auditors, we have the potential to address, examine and understand any kind of complex medical device regulation. This will be helpful for you to get consistent expert advice and opinions.
- We support our clients with required UKCA Technical Documents, Clinical, and Biological Evaluation Documentation as well as helping in implementing ISO 13485 standards beyond just having registration of UKRP and MHRA.
- Apart from providing all-inclusive services that applies to a UK Responsible person, you will get all services to meet compliance and get certifications.
- We offer free services toward the Identification of suitable GMDN codes.
- We perform clinical investigation and evaluation, Risk Analysis vs Benefits report.
- We offer several payment options as applicable in different countries.
- The Responsibilities of MHRA UK Responsible Person.
- Making sure that appropriate medical device classification is being followed.
- Ensuring that the manufacturer sticks to the newest technical documentation as well as Declaration of Conformity (DOC).
- Ensuring that the device manufacturer has taken into consideration all relevant conformity evaluation procedures.
- Keeping a copy of the product’s technical documentation for inspection purposes by the MHRA.
- Keeping close coordination with the manufacturer to produce any sample or submit papers as decided by MHRA.
- Providing the MHRA department with all required information and documents as asked by it from time to time.
- Cooperating with both the MHRA and the device manufacturer in the event of any CAPA action is taken to discard possible risks.
- Informing the manufacturer if any act becomes conflicting with its compulsions under the regulation of MHRA.
- Informing the manufacturer regarding incidences and complaints that raise from the market after launching the product instantly.
- If required, the UK Responsible Person gets in touch with the manufacturer if any important notification is received from MHRA depending on its importance.
- Opening a registration account as an officially authorized representative of the manufacturer operating on its behalf.
Supporting PMS activities.
It has been made mandatory to obtain MHRA Registration to sell, rent or provide machines on lease for any kind of medical device and In-Vitro Diagnostic implement in the UK market. So, make sure to be prepared to get registered with MHRA if you are on the doorstep to market your medical device in the UK. The UK MDR 2002 needs you to convey the MHRA, the areas where your product will be marketed before it enters into the market. Designating the UK Responsible Person having a registered address to operate a business in the UK is a must for foreign manufacturers.
Below listed are the Medical Devices That Require Registration with MHRA
- Medical devices that are used for implantation purposes
- Decides for implantation which is categorized under Class IIb
- Medical devices categorized under Class III
- IVD Listed products
- Non-implantable medical devices that come under Class IIb
- All medical devices categorized under Class IIa
- IVD Listed B products
- Self-testing IVDs
- Medical devices that come under the Class I group
- General IVDs
MHRA Registration Rule
MHRA Registration needs to be renewed after one year of having registration or confirmation has been made in an interval of 2 years after that date.
Failure to get your registration renewed will lead to the removal of all your records from our databank. Thereafter, you will need to undergo the complete registration process or otherwise, you can no more market your medical device on the UK marketplace.
What are the Documents Required for MHRA registration?
Information of the Manufacturer
- The name, contact details (address), telephone number, and email address of the legal manufacturer. Different activity areas of the legal manufacturer.
- The name, contact details and email address of the UK Responsible Person.
- Official agreement copy made between the UK Responsible person and Manufacturer
The Annual fee of UK Responsible Person and MHRA registration will be given upon request through “firstname.lastname@example.org”