Medical Device Registration in UK

Table of Contents

Authority for Medical Device

Manufacturers must register their devices with the Medicines and Healthcare products Regulatory Agency (MHRA) before placing them onto the Great Britain market.

Medical Device Definition

“medical device” means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which—

(a)is intended by the manufacturer to be used for human beings for the purpose of-

(i)diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii)diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(iii)investigation, replacement or modification of the anatomy or of a physiological process, or

(iv)control of conception; and

(b)does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

“in vitro diagnostic medical device” means a medical device which—

(a)is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

(b)is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—

(i)concerning a physiological or pathological state,

(ii)concerning a congenital abnormality,

(iii)to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

(iv)to monitor therapeutic measures, and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination;

Medical Device Classification

Devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42.

Medical Device Registration Pathways:

Devices must be CE marked or UKCA marked before they can be registered.

Where the manufacturer is not located in the UK, their appointed UK Responsible Person (UKRP) must register devices on the manufacturer’s behalf.

The registration is more of a notification process. The registration is not intended to validate device safety or efficacy. In fact, the MHRA’s registration confirmation letter and registration guidance both explicitly state that the registration does not constitute an approval or certification of the device.

Document Requirements

The registration process is relatively straight-forward, with the following (non-exhaustive list) information requested:

- Proof of UKRP appointment, e.g., Letter of Designation or Agreement (non-UK manufacturers only)
- Manufacturer legal name & address
- Regulation to which the device conforms, for example, the Medical Devices Directive 93/42/EEC
- GMDN code
- Device classification
- Whether it’s labeled as sterile, and if so, method of sterilization
- Whether the device is implantable; active; single-use; etc.
- Copy of the applicable verification of conformity assessment, for example, a CE marking Certificate or Declaration of Conformity, as applicable
- Device name, model(s) and catalogue numbers
- In which UK countries the device will be placed

Fees

The MHRA charges a fee of £100 for each registration. Companies can submit up to 100 device registrations under that £100 fee, if all are registered at the same time.

Timeline

The MHRA quotes a five-business day timeframe to review applications. However, the review time may be extended if the MHRA has a backlog of registrations to process.

The MHRA can request to review more information about the device during their review. For example, the assessor could ask to receive more information about the classification rationale, request a copy of the instructions for use or images of the device. This would increase the review time.

Advantage for choosing an independent authorized representative / UK Responsible Person (UKRP)

Avoid conflict of interest from local distributor
Reduced fee if direct shipment to end users
Add or change distributors as required
Professional handling of post market vigilance and license maintenance
UKRP is well verse in regulatory requirements / comply to MHRArequirements easily without repercussion from authority