Countdown to the final UK MDR: changes Importers and Distributors need to be aware of
The final UK Regulation text is due to be published from Spring 2023, and new Post-Market Obligations must be implemented by Importers and Distributors providing UKRP services in 2023.
New UKRP rules for Importers and Distributors
The most critical change introduced by the new UK MDR is that Importers and Distributors currently acting as UK Responsible Persons (RP) will become legally liable for suppliers’ products, but they will also need to meet a range of other conditions including:
- More MHRA scrutiny
- More obligations relating to technical documentation
- Hiring more specialised staff
- Stricter location of address conditions
Plan ahead: 3 critical changes for acting UKRPs
In the paragraphs below we’ll address 3 critical changes that Importers and Distributors acting as UKRPs need to start preparing for before the final UK Medical Device regulation is published in spring 2023:
- UKRPs will become legally liable on a par with manufacturers
- UKRPs will have to appoint at least oneQualified Person (QP) to be permanently and continuously at their disposal
- UKRPsmust be physically located in the UK
1. UKRPs will become legally liable
Importers and Distributors acting as UKRPs will become legally liable for faulty medical devices on the same basis as manufacturers and may therefore be proceeded against in the UK. Therefore they will need to hold and demonstrate appropriate liability insurance, covering also wider factors such as cyber risk, hacking and compromised privacy data.
To support them with these new responsibilities, Importers and Distributors 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.
To this end, UKRPs must 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 other stakeholders and these aspects should be considered and clearly outlined in company policies, procedures and agreements. At the same time, data storage systems must meet any other legal requirements, such as GDPR.
2. UKRPs must have at least one Qualified Person (QP) permanently and continuously at their disposal
In addition to this, UKRPs will 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.
Further clarity from the government is needed when it comes to QP definition and requirements, but in the interest of protecting their business Importers and Distributers should start to plan to have at least one QP, with a suitable regulatory and medical background, permanently and continuously available.
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.
Importers and Distributors acting as UKRPs without a valid UK address should start planning immediately to ensure they do not fall foul of regulation.
Outsourcing UKRP services to avoid conflicts of interest
It’s also important to keep in mind that in addition to what outlined above, the new UK Medical Regulation requires UKRPs to place their details on all supplier devices, causing possible conflict of interest for Importers and Distributors that normally deal with competing manufacturers.
Savvy Importers and Distributors should start to consider separating their commercial and regulatory activities to stay competitive, avoid conflict of interests, liabilities and penalties by introducing their clients to alternative UKRP service providers before issues arise.
Visit our website to discover how IMED Consultancy’s proven international medical regulatory experience can help you stay ahead of new regulations and UKRP requirements!
Strategic Development Director