Compliance
MHRA Compliance
Meeting the requirements of the UK regulator for medicines and medical devices, a precondition for many NHS supply contracts.
Definition
MHRA compliance means meeting the regulatory requirements of the Medicines and Healthcare products Regulatory Agency, the UK body responsible for regulating medicines, medical devices and blood components. For suppliers bidding into the NHS and other public health bodies, it is usually a threshold requirement rather than a scored criterion: a bid for regulated products that cannot evidence the correct registration, marking and vigilance arrangements will not proceed regardless of price or quality.
How it works in practice
The obligations depend on what is being supplied. Manufacturers and UK Responsible Persons placing medical devices on the Great Britain market must register the device with the MHRA and hold the appropriate conformity marking, currently either UKCA marking or, under transitional arrangements, CE marking recognised for the Great Britain market. Northern Ireland follows a separate route under the Windsor Framework. Medicines carry their own regime of marketing authorisations, manufacturing and wholesale dealer licences, and Good Manufacturing Practice and Good Distribution Practice obligations.
Beyond placing a product on the market, suppliers carry continuing duties. Vigilance reporting requires manufacturers to notify the MHRA of serious incidents and field safety corrective actions within defined timescales. Post market surveillance requires an active system for collecting and reviewing product experience. Traceability obligations require records sufficient to identify affected units in a recall. These are the duties buyers most often probe in clarifications, because they determine what happens when something goes wrong on the contract rather than at the point of sale.
In tender documents, MHRA related requirements usually appear in the selection questionnaire and the specification rather than in the award criteria. Suppliers should expect to provide registration numbers, evidence of conformity assessment, quality management system certification such as ISO 13485, and a summary of the vigilance and recall process. Regulatory non-compliance can also engage discretionary exclusion grounds where it amounts to grave professional misconduct.
Common questions
Does MHRA registration replace CE or UKCA marking?
No. They are separate obligations. Conformity marking evidences that the device meets the applicable essential requirements through the correct conformity assessment route. Registration notifies the MHRA that the device is being placed on the market. Both are needed, and buyers commonly ask for evidence of each.
Do distributors have obligations, or only manufacturers?
Distributors and importers have duties too. These include verifying that products carry the correct marking and registration, maintaining traceability records, cooperating with corrective actions, and not supplying products they know or suspect to be non-compliant. A distributor bidding into the NHS should expect these to be tested.
Is ISO 13485 required?
Not as a matter of law in every case, but in practice it is close to essential. ISO 13485 certifies a quality management system for medical devices and is the normal route to demonstrating the systems that conformity assessment and NHS buyers expect. Many NHS frameworks make it a mandatory selection requirement.
What happens if a product is recalled during a contract?
The supplier must follow its field safety corrective action process, notify the MHRA within the required timescale, and inform affected customers. Public sector contracts typically add their own notification and remediation obligations, and sustained or badly handled failures can result in a Contract Performance Notice under the Procurement Act 2023.
