In the UK, the post-market surveillance (PMS) regulations are being revised. In this article, we look at examples of incidents that the Medicines and Healthcare products Regulatory Agency (MHRA) classifies as reportable under the new regulations.
Update to Post-Market Surveillance Regulations in the UK
In the UK, vigilance and reporting requirements have been tightened by the MHRA.
The changes cover all medical devices that placed on the UK market after 16 July 2025 or (with minimal differences) on the Northern Irish market.
In this article, we present the new vigilance and reporting obligations for manufacturers using the example of a few selected product groups.
The information presented here is a summary of various guidelines issued by the MHRA for the purpose of informing manufacturers. The article does not claim to be exhaustive.
For professional advice, it is best to contact the experts at BEO BERLIN.
For an overview of the changes and the division of responsibilities, we recommend taking a look at this guidance document from the MHRA.
A selection of device-specific post-market surveillance requirements from the MHRA
For intraocular lenses, incidents must be reported if, among other things, the following problems occur:
- Lens clouding or opacity
- Removal of the lens due to decreased visual acuity, glare/halo/starburst effects, double vision, lens defects, infections, cataracts, bleeding, poor visual results or capsular rupture/opacification.
- Fracture or detachment of the lens
- Incorrect labelling of the lens (including strength)
- Failure of the lens injectors
For insulin pumps and integrated meter systems , the MHRA stipulates a reporting obligation for manufacturers in the following cases:
- Patient-related events: Death, severe hypo-/hyperglycaemia (with loss of consciousness/coma), diabetic ketoacidosis, unexpected necessary interventions.
- Product-related incidents: Failure of alarm, pump, power or display/control functions, incorrect readings, software or connection errors, fluid leakage, safety-related software problems.
For software as a medical device (digital health applications) , the MHRA explains that incidents occur in particular as indirect harm to patients.
In general, if the three reporting criteria for incidents or serious incidents are met, the manufacturer is obliged to report them. The three reporting criteria are summarised as follows:
- An incident has occurred.
- The incident has resulted in death/a serious deterioration in health/a serious threat to public health, could have resulted in this, or could result in this.
- A causal link with the product has been proven or cannot be ruled out.
The MHRA also lists examples of indirect damage:
- Incorrect or false diagnosis
- Delayed or missed diagnosis
- Delayed, absent or incorrect treatment
Our Recommendation to Manufacturers
We advise all manufacturers operating in the UK medical device market to familiarise themselves with the changes and establish systems that meet the new requirements and can record and report incidents
As an experienced partner for UK-Rep Services, BEO BERLIN works with you to implement the appropriate systems and mechanisms. Naturally, we do so in a spirit of partnership, professionalism and pragmatism. This enables you to achieve maximum reliability in vigilance and market entry with minimum effort.
Please contact us if you have any questions!
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