The new article highlights aspects related to the information to be included in the submission in order to ensure its completeness.
Table of Contents
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document dedicated to the registration processes and procedures to be conducted in order for medical devices to be allowed for marketing and use in the UK. The document provides an overview of the applicable regulatory requirements set forth under the existing framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. At the same time, provisions of the guidance are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to introduce changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Registration: Timing
First of all, the authority explains when an application for registration of a medical device should be submitted. Under the general rule, any and all products subject to regulation as medical devices should be registered with the MHRA before they are available in the country.
Starting January 1, 2021, medical device manufacturers based abroad are obligated to appoint a UK Responsible Person to act as their authorized representative for the purpose of communication with the regulating authority and performing other functions. Furthermore, the authority additionally emphasizes that an authorized representative based in Northern Ireland cannot represent medical device manufacturers intending to market their products in Great Britain.
A similar approach applies with respect to medical device registration in Northern Ireland. At the same time, registration requirements will not apply with respect to Class I medical devices or in vitro diagnostic devices (safe for those intended for self-testing) in the following cases:
- The manufacturer is based in the EU, EEA, or
- The manufacturer is based outside Northern Ireland, the EU, or the EEA and has appointed an EU-based Authorized Representative.
Information to be Provided
The document further outlines the scope of information the authority expects the applicant to submit when applying for registration of a medical device intended to be marketed in Great Britain. The authority also mentions that the list of elements provided in the guidance is non-exhaustive and reserves the right to request additional information, should it be reasonably necessary to assess the aspects related to the safety, effectiveness, and proper performance of a medical device subject to review, including additional technical documentation or validation data.
With respect to the medical device manufacturer responsible for the product, the authority expects the following information to be provided:
- Name of a legal entity and its contact details (including details) in a way it will be reflected on labeling;
- The legal form of the entity;
- Contact persons;
- Destination letter for an authorized representative (an agreement with the latter, outlining the functions to be performed when representing the manufacturer).
With respect to the last point, the authority refers to a separate guidance document dedicated to the regulatory status of a UK Responsible Person.
With regard to the product itself, the information to be provided should include:
- An indication of the applicable regulatory framework;
- An indication of a class in accordance with the applicable risk-based classification;
- Code and Term under the Global Medical Device Nomenclature;
- Basic UDI-DI (if applicable);
- Medical device name (brand/trade/proprietary name);
- Model or version detail;
- Catalogue/reference number;
- UDI-DI (if applicable);
- UK Approved Body (or EU Notified Body) where applicable;
- Attributes such as sterility, contains latex, MRI compatible.
Apart from the above, the authority also expects the applicant to submit copies of all the conformity assessment certificates available, as well as self-certification conformity declarations.
Custom-Made Devices
According to the guidance, additional rules apply in the case of custom-made devices. For instance, in the case of implantable ones, the applicant should also submit a copy of the instructions for use, as well as the labeling to be used when supplying the device. The authority also encourages interested parties to get in touch in advance in case they are:
- Based outside the UK; and
- Do not have an Authorized Representative based in Northern Ireland; and
- Are willing to market their products only in Northern Ireland.
Systems and Procedure Packs
The registration requirements described above also apply to systems and procedure packs. Registration will be required for an entity intending to place a system or procedure pack on the market under its name. This applies to products marked with UKCA, CE, and CE UKNI marks. Registration will also be required for sterile medical devices. According to the guidance, manufacturers are obliged to:
- Register each system or procedure pack using GMDN;
- Add at least one underlying product;
- Upload a list of all the possible components that might be included in the system or procedure packs for that GMDN.
IVDs Under Performance Evaluation
The document also outlines special rules to be applied in the case of in vitro diagnostic medical devices undergoing performance evaluation. In this respect, the authority points out the following:
- All such products should be registered before the commencement of the study;
- The products involved in an ongoing study should be registered as well;
- In the case of a foreign medical device manufacturer, the appointment of a local representative will be required;
- A Declaration for Performance Evaluation should be submitted for all the studies.
In summary, the present MHRA guidance highlights the key points to be considered when applying for registration of specific types of medical devices. The document also provides an overview of the general regulatory requirements, including the scope of information to be included in the submission.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.
