The MHRA issued new requirements for manufacturers and importers regarding the post-market surveillance of medical devices in June 2025.
In this article, we discuss which products are subject to the new regulations, which relevant periods must be observed, and which types of incidents are reportable and how they are defined.
We have already reported on the new obligations for manufacturers and the plans of the MHRA.
Scope of Application of the New Requirements
The updated post-market surveillance (PMS) obligations for manufacturers and importers apply to all medical devices placed on the UK market after 16 July 2025. However, there are some exceptions: The measures do not apply, or only apply to a limited extent, to the following medical devices (hereinafter referred to as ‘products’):
- Products that are subject to a performance or clinical study – i.e. those that are already documented in a registered test series.
- Products that have a ‘valid exceptional use authorisation’ within the UK.
- Discontinued products: Products that will no longer be available on the UK market after 16 July 2025.
- For products that were placed on the UK market before 16 July and remain on the UK market without modification, the old and new PMS regulations may apply simultaneously. It is recommended to comply with the new regulations, as they are more consistent and cover the old requirements.
It should be noted that even products to which one of these exceptions applies are generally subject to the PMS requirements that have been in force to date – the monitoring obligation of manufacturers for existing products does not expire with the introduction of the new regulations.
For the relevant MHRA guidance document, click here.
Duration of the Manufacturer's Monitoring Obligation
- Commencement: Placing on the market or first use of the device
- End: When the device reaches the end of its specified service life (expiry date) – even if the device remains in use and continued use is expected.
For an overview of the definitions of the life span of medical devices and the associated PMS obligations, see ‘Figure 2 – PMS period’.
Scope of Incidents to be Reported
The MHRA stipulates a reporting obligation for serious incidents. Other incidents do not necessarily have to be reported, but they must be documented. It is recommended (and in some cases necessary) to submit so-called Periodic Summary Reports (PSRs) to the MHRA. For a good overview of the documentation requirements for manufacturers, read our article on this topic.
In order to reliably meet these requirements, the implementation of a post-market surveillance system is necessary.
Which Incidents must be Reported and Documented?
The MHRA defines incidents as follows:
- Incident (subject to documentation):
- Malfunctions or loss of performance of the product when used as intended.
- Incorrect diagnoses or measurement results that influence clinical decisions.
- Design or utility defects, including insufficient information or instructions.
- Side effects with negative effects on patients, users or public health.
- Serious Incident (reportable):
- Death of a person
- Serious deterioration of health*
- Danger to public health**
- *Serious deterioration in health (reportable):
- Life-threatening illness or injury
- Permanent impairment of a bodily structure or function
- Hospitalisation or extension thereof
- Necessary medical treatment (including self-treatment) to prevent life-threatening or permanent damage – even if this could only be avoided or mitigated through early intervention.
- Chronic illness
- Foetal complications (distress, death, malformation)
- Serious threat to public health (notifiable)
- Risk of death, serious illness or deterioration in health on a large scale within the population, requiring urgent action.
- Other occurrences
- Not individually reportable, but must be documented in the PMS system, reported to the MHRA as part of the trend reports and included in the Periodic Safety Update Report (PSUR) or the Post-Market Surveillance Report (PMSR).
A PMS system must have mechanisms in place that can detect incidents, systematically classify them and inform the responsible persons about the incident so that this information can be forwarded to the competent authorities (MHRA).
Our Recommendation to Manufacturers
The MHRA requirements largely correspond to the existing requirements regarding PMS in the UK.
Nevertheless, there are significant changes that manufacturers should take seriously – particularly with regard to data collection and systematic incident detection.
Professional support can be helpful when implementing a PMS system. So don't hesitate to take advantage of the services offered by BEO BERLIN. As an experienced UK representative, BEO BERLIN can assist your company with regulatory matters and relieve you of bureaucratic burdens. Naturally, we offer professional service and partnership!
