Previous articles on The Windsor Framework discussed the human medicine deal arrangement between Great Britain and the Northern Ireland markets. On 7 June 2023, MHRA updated the medical device registration for the Great Britain and Northern Island markets. The guidelines covering up for all requirements needed by the manufacturers, Authorized Representatives and Responsible Persons.
The manufacturers must ensure all the medical devices, in-vitro diagnostic devices (IVDs), custom-made devices and systems or procedure packs, are registered under MHRA and comply with the Medical Devices Regulations 2002. There are only 3 parties that are eligible for registration which are the manufacturers, the UK Responsible Persons (UK based) and the Authorized Representatives (Northern Ireland based) for the Northern Ireland market.
1. Whom Party Compulsory to Register
Medical Device Registration for placing in the Great Britain market
It is required for any manufacturer from outside of the UK to designate one UK Responsible Person to be responsible for all medical device registration processes. In cases of Great Britain importers are non-UK Responsible Person, the importer must inform the involved manufacturer or the UK Responsible Person of the importing intention and provide the importer details for MHRA.
Medical Device Registration for placing in the Northern Ireland market
Non-UK manufacturers: not required to hire UK Responsible Person
Manufacturers from outside Northern Ireland, or from EU countries: required to hire an EU Authorized Representative, or, Northern Ireland Authorized Representative
Great Britain-based manufacturers: required to hire an EU or Northern Ireland Authorized Representative. It is important to note that, if an EU Authorized Representative is hired, all medical devices must be registered with MHRA by the manufacturers, except for Class I medical devices and non-self-testing general IVDs. While if the Northern Ireland Authorized Representative is hired, the representative is responsible for all the registration.
Importers Registration
If the person responsible to place the products is not the manufacturer or the Northern Ireland Authorized Representative, the representative is required to attach all the related details of the person to the MHRA.
Custom-made devices Registration in Northern Ireland
The manufacturer is required to register the devices within 28 days of being available on the Northern Ireland market and must comply with the legislation.
2. Registration Period
3. Requirement Information for Medical Devices MHRA Registration
The requirements listed are divided into 2 parts: manufacturer details and device details. Note that, MHRA may request any additional information other than the listed information to assist with the registration process.
For custom-made active implantable device registration, manufacturers are required to submit a copy of the usage instruction and the device labeling to the MHRA. While for systems and procedure packs, any medical devices that are placed on the market with own name within intended purposes and carrying UKCA, CE or CE UKNI marks, must be registered to the MHRA. It is also applicable for the devices intended to be sterilized before use or already sterilized before placing in the market.
4. IVDs under Performance Evaluation
It is compulsory to register any IVDs that will undergo new performance evaluation studies in the UK, or ongoing evaluations that begin before 31 December 2020. While for non-UK manufacturers with devices that will undergo performance evaluation, it is required to designate a UK Responsible Person to proceed with the registration. Declaration for Performance Evaluation, based on UK MDR 2022, is required for all performance evaluation studies.
5. Device Online Registration System (DORS) Application
The manufacturer is required to register an account on MHRA DORS and will get replied for accepted confirmation or rejection confirmation. The manufacturer is responsible to ensure all the information provided is up to date and only will be valid as a registered device once received confirmation. For any registration by UK Responsible Person or Northern Ireland Authorized Representative, the manufacturer details are compulsory to attach during the registration.
6. Review Registration
As the Regulation 7A for general medical devices, Regulation 33A for in vitro diagnostic medical devices and Regulation 21A for active implantable medical devices of the UK MDR 2002, it is compulsory for manufacturers to review the registration frequently.
A new registration process has been executed which manufacturers can start to renew 1 year after the account is approved by the MHRA, which later can be continued by every 2 years at least. Reminders will be sent starting from 3 months prior to the renewal date, followed by 2 months prior and 1 month before the renewal date. The review is intended to ensure all the information is up-to-date. The account will be suspended if there is no registration review and will be removed from the Public Access Registration Database (PARD). This will affect manufacturers to add new devices or order Certificates of Free Sale.
For any changes to be made after the registration, the manufacturer may log in to MHRA DORS to make changes to the information. There are some changes that will incur fees, for example, address, company name, changing of UK Responsible Person or uploading new Hiring Letter for represented manufacturers. While for changes like, Renew Registration application submission, contact information updates or device removal, will not be charged any fee.
7. Public Register of Manufacturers
Finally, the company name, address and registered medical devices will be published in the Public Access Registration Database (PARD). For IVD medical devices that undergoing performance evaluation study will not be published on this site.
Source: MHRA
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