The final UK Regulation text is scheduled to be published from Spring 2023, so manufacturers should be assessing their current provider to ensure they meet the compliance requirements to keep their devices in the UK market.
UK MDR: new requirements for UKRPs and consequences for manufacturers
With the new UK MDR, UKRPs will not only be liable for suppliers’ products but will also be at risk of not complying with the latest requirements and a growing range of conditions, including:
- More MHRA scrutiny
- More obligations relating to technical documentation
- Hiring more specialised staff
- Strict location of address conditions
Manufacturers that want to keep their product on the UK market should be aware of the changes introduced by the new UK Regulations and check with their appointed UKRPs to make sure to be fully compliant when the time comes.
Better safe than sorry: key points to discuss with your appointed UKRP
In the paragraphs below we’ll address 3 critical changes manufacturers need to discuss with their current UKRP to make sure they are starting to prepare for when the final UK Medical Device regulation will be published in summer 2024:
- UKRPs will become legally liable and will be required to have at least oneQualified Person (QP) permanently and continuously at their disposal
- UKRPs must retain access to technical documentation relating to all devices after manufacture
- UKRPs must be physically located in the UK
1. UKRPs will become legally liable and will be required to have at least oneQualified Person (QP) permanently and continuously at their disposal
Once the final UK MDR is implemented, UKRPs will become legally liable for faulty medical devices on the same basis as the manufacturers and will therefore need to hold appropriate liability insurance, also covering wider risk factors, such as cyber risk, hacking and compromised privacy data.
UKRPS will also be required to have at least one Qualified Person permanently and continuously at their disposal. All Qualified Persons will be required to have qualifications or regulatory experience that exceeds minimum standards, which will be clarified in the Regulation but will probably align with EU Regulations and international standards. Further clarity from the government is needed when it comes to QP definition and requirements, but in the interest of protecting their business manufacturers should make sure their appointed UKRP has available capacity, intends to continue offering legal services after the UK MDR is fully applicable and has arranged to have at least one QP permanently and continuously available.
2. UKRPs must retain access to technical documentation relating to all devices after manufacture
The changes to the UK Regulations will require UKRPs to address certain new requirements in writing. Specifically, they will need to retain technical documentation for the entire expected lifetime of a device, i.e., 10 years for non-implantable devices and 15 years for implantable devices, even when the manufacturer ceases activity or in case of UKRP change.
Manufacturers should therefore make sure their acting UKRPs are planning to ensure appropriately secure systems for the storage and protection of patient data throughout the specified data retention periods. Data should be retrievable at the request of Authorities and any other stakeholder and these aspects should be considered and clearly outlined in company policies, procedures and agreements whilst at the same time must meet any other legal requirements, such as GDPR
3. UKRPs must be physically located in the UK
The new UK MDR states that every UKRP must have a valid UK address at which they are physically located. This means UKRPs operating by uploading a “forwarding address” to the MHRA registration system will no longer be permitted to legally operate on this basis.
Manufacturers relying on acting UKRP without a valid UK address should make sure they are planning to change their business model or to outsource their UKRP services to comply with the new regulation.
Consider all your options to protect your business after the UK MDR publication
The UKRP role has so far been a transitional arrangement, but liability and new obligations are nearly upon us. Now is the perfect time to assess the ability, expertise and capacity of your appointed UKRP and to make sure they are ready for the changes ahead. Some UKRPs may even decide to suspend their UKRP service if they are unable to comply with new regulation, are unwilling to operate with new requirements and liabilities or lack capacity or expertise.
It’s better to avoid looking for a new UKRP at a time when industry reaches a pinch point and particularly if manufacturers find their devices ‘orphaned’. Be one step ahead and make sure now your UKRP has the available expertise and resource to act on your behalf and that they are representing your best interests.
Visit our UKRP website to discover IMED Consultancy’s UKRP services, backed by proven international medical regulatory experience that can help you stay ahead of new regulations!
Strategic Development Director