Entering the UK Market: Medical Devices

The United Kingdom medical device legislation governs the placing of devices on the Great Britain market. Devices must be registered with the MHRA and foreign manufacturers must appoint a responsible person established in the United Kingdom.

For foreign manufacturers a UK RESPONSIBLE PERSON IS MANDATORY: MHRA registration is made through that party and it carries responsibility before the legislation.

• Device description, classification and intended purpose
• Technical documentation
• Quality management system records
• The UK Responsible Person appointment agreement
• The MHRA registration record
• A notified body certificate (where required)

1. 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
2. 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
3. 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
4. 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
5. 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
6. 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
7. 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
8. 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.

• Registration cannot be made without appointing a UK Responsible Person
• Transitional arrangements for the acceptance of CE-marked devices are conditional
• EU rules apply for Northern Ireland
• The device class determines the route to be followed

1. 01UK MDR and EU MDRThe national regime rests on the EU's old directive arrangement, while the EU moved to the new regulation. The evidential thresholds are no longer the same and the documents are not treated as mutually valid.
2. 02Great Britain and Northern IrelandEU rules continue to apply in the region; two regimes can be valid for the same device within the same country and marking is established accordingly.
3. 03National registration and body assessmentRegistration is not an approval; assessment by a designated body is also required according to the risk class. Neither takes the place of the other.
4. 04The responsible person and the authorised representativeAn authorised representative established in the EU is not valid under this regime; a responsible person established in the country is appointed and is the point of contact with the authority.

There is no separate certification page for this mark; the scope and process are as described on this page. The roadmap specific to your product is provided in writing at the quote stage.

This section's content is being prepared. The roadmap specific to your product and target market at the quote stage in writing.