Release of the UK draft
Last week brought an important update for medical device manufacturers- the UK released a new draft guidance outlining requirements for post-market surveillance. The guidance was published alongside a request for public feedback over the next 60 days. Per the World Trade Organisation, the draft will likely be finalized this winter and come into full effect by mid-2024. That may seem like the distant future, but it’s closer than you think. For manufacturers, preparation is key. Proactive companies will want to review the draft language now and assess any impacts to their current systems and protocols.
This article is an overview of the guidance. However, we’ve done a more in-depth look at the requirements for you. For a more detailed summary, download our cheat sheet here!
Overview of the Requirements
The draft guidance includes requirements for the following areas:
- Maintaining a PMS system for each device on market or in service that is proportionate to risk and includes device-related data
- Identifying and taking corrective and preventive actions
- Timeframes for taking action and reporting incidents to the Secretary of State in the event of serious, public health or patient harm incidents
- Development of PMS plans, reports, and period safety reports depending on device classification
- Actions to be taken by manufacturers at the direction of the Secretary of State
- Record retention within the PMS system
How Does this Compare to EU MDR?
Overall, the UK draft guidance is mostly aligned with EU MDR requirements, which is good news for manufacturers already working in the EU space. One key difference is around document retention.
EU MDR requires records be kept for 10 years minimum after a device is last marketed, or 15 years minimum for implantable devices. The UK draft states records should be kept for the device’s full post-market surveillance period plus 10 or 15 years depending on device type. Since the surveillance period runs through a device’s entire lifetime, the UK retention timeframe could end up being longer.
In summary, manufacturers may need to retain PMS records for a longer period under the new UK guidance compared to EU MDR.
What This Guidance Means for Manufacturers
While the new requirements add responsibilities around safety and vigilance, the aim is increased protection for patients and the public.
For manufacturers, preparation and adjustment will be key. Companies will need to review current PMS procedures against the UK draft to identify any gaps in areas like reporting, record retention, and working with UK authorities.
The good news is that, as noted above, the draft aligns closely with EU MDR. Manufacturers compliant with EU MDR will already have a strong foundation for PMS systems and should be able to adapt to the UK requirements easily.
Stay Ahead of the Changing Regulatory Environment
At MedLark, we track regulatory changes globally so manufacturers can focus on their core mission. For companies looking to efficiently align with new UK regulations, we can provide:
- Gap assessments comparing your current PMS system to the draft
- Remediation plans tailored to your specific devices
- Ongoing audits or advisory services regulations continue to evolve
Medical Device Consultant | Regulatory & Quality System 
Leave a comment