An overview of the top 10 questions regarding the UK Responsible Person & medical device and IVD registration with the MHRA. The questions are the questions are divided into 6 different topics: grace period, classification, labeling, information and documentation for registration, access database, and Notified Body/UK Approved Body.
Grace Period
Q: What are the timelines for appointing a UK RP and for registration of medical devices and IVDs?
The MHRA guidance states that a manufacturer must appoint a UK RP as soon as possible. The MHRA has provided a grace period for the registration of medical devices and IVDs in order to allow time for compliance with the new registration process. Medical devices and IVDs must be registered with the MHRA as per table 1.
Qserve advises to register devices ahead of these dates, but there will be no legal obligation until the end of the grace period.
Classification
Q: Will the MHRA issue a list of recognized GMDN codes for registration in the UK and is the GMDN code compulsory even it is not mandatory in the EU?
It is compulsory to list the GMDN code during the registration process. Without the GMDN code the registration of the device cannot be completed. If a manufacturer does not have a GMND code, Qserve can support the manufacturer in identifying the appropriate GMDN code.
The MHRA has not listed an overview of recognized GMDN codes for the public as this would be against the GMDN Agency policies.
During the registration process of a device into the UK database, all GMDN codes can be searched for. This means that the list of GMDN codes in the UK database is always up to date with the GMDN Agency.
Labeling
Q: Does a manufacturer have to place the UK RP name and address on the labeling and packaging or is the current labeling and packaging valid until 30 June 2023?
The labeling and packaging of devices placed on the Great Britain market based on the EU MDD/IVDD or EU MDR/IVDR do not have to change until 30 June 2023. This means that the current labeling and packaging including the CE mark remain valid. The name and address of the UK RP do not need to be on the label and packaging until 30 June 2023.
Q: Can devices bear the CE mark as well as the UKCA mark on the labeling and packaging?
Devices can have both the CE mark as well as the UKCA mark present on the labeling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023.
Information and documentation for registration
Q: What type of information is required for the database registration?
There are three levels of information: 1. manufacturer details, 2. device details and 3. product details.
Manufacturer details include the name, address and contact person of the organization
Device details include high level details based on the GMND code. Among other things, this includes the risk classification, technical specifications such as sterile or non-sterile device, single or reusable device and compliance to EU MDD/IVDD MDR/IVDR. Furthermore, the conformity assessment certificate and declaration of conformity must be provided.
Product details include the specific device name (brand/trade/or common name), device model(s), catalogue number(s)/reference(s), contra-indications, and critical warnings. For manufacturer’s with a large product portfolio, the MHRA has made available a specific template for ‘bulk upload’ which can be used to upload all information into the database.
Q: Is the feature ‘bulk upload’ available for all GMDN codes combined?
No, bulk upload is not possible for all GMDN codes combined. The feature ‘bulk upload’ can only be used for device models per GMDN code. For example; the registration of 1 GMDN code, including 150 different device models, can use the bulk upload for the registration of the 150 device models.
Q: Does the UK RP require access to the technical documentation?
The UK RP will need to have access to the technical documentation in one or another way. It can be a hard copy or e-copy, or a link to the manufacturer’s documentation system. Qserve prefers to have a contact person at the manufacturer that is available for the UK RP to answer and discuss specific questions regarding the technical documentation and where to find them as well as for vigilance and incidents.
Q: Can the Letter of Designation be replaced by the contract between the manufacturer and UK RP?
The Letter of Designation and the contract between the manufacturer and UK RP are two separate documents. The Letter of Designation includes standard text provided by the MHRA. This letter must be uploaded in the database. Next to this, Qserve has written a contract between the manufacturer and UK RP to identify the responsibilities included in the UK RP service. Hence, the Letter of Designation cannot be replaced by the contract between the manufacturer and UK RP.
Access database
Q: Will the MHRA database be open to the public?
Once the manufacturer and medical devices are registered with the MHRA, some details will be accessible through the Public Access Database for Medical Device Registration. This database will not show all device and product details, but it will show high level details. This includes the manufacturer name, address, UK Responsible Person, registration date, MHRA Reference Number and all devices registered with the MHRA by GMDN term.
Manufacturers of IVDs are not published on this database, due to the IVD confidentiality clause. Click here to navigate to Public Access Database for Medical Device Registration.
Notified Body/UK Approved Body
Q: What is the difference between a Notified Body and UK Approved Body? When does a manufacturer have to use a UK Approved Body?
A Notified Body is a EU-recognized body that can undertake a conformity assessment and grant approval for EU market access for devices that comply with the EU MDD/IVDD and EU MDR/IVDR. This allows the manufacturer to bear the CE mark on the labeling and packaging of the device after approval of the Notified Body. A manufacturer can then place the CE marked devices on the Great Britain market until 30 June 2023.
A UK Approved Body is a new conformity assessment body that has been designated by the Secretary of State. This means that former known Notified Bodies located in the UK are not automatically becoming a UK Approved Body.
The role and tasks of a UK Approved Body are in essence similar to those of a EU-recognized Notified Body however the UK Approved Body will grant approval for UK market access for devices that comply with the UK MDR. This allows a manufacturer to bear the UKCA mark on the labeling and packaging of the device after approval of the UK Approved Body.
Click here for a list of all Approved Bodies. The Secretary of State is continuously updating the list.
Do you want more information regarding our UK Responsible Person service? Please feel free to contact us or visit our dedicated UK Responsible Person webpage.