Have you appointed the right UKRP? Part 3
This is the 3rd article in a 3 day, 3-part series which considers some of the upcoming changes to the UK devices regulations and the implications on the UKRP legal service.
Response to Consultation, 12.2,
The changes to the UK Regulations will require the Manufacturer and their UKRP to address certain new requirements in writing.
· Data retention
UKRPs to retain (or have access to) technical documentation relating for the expected lifetime of a device after the product has last been manufactured or 10 years for non-implantable devices (whichever is longer). 15 years for implantable devices
· Where the manufacturer ceases activity (eg. Liquidation).
UKRPs to retain device documentation for the same time periods, as outlined above
· UKRP change
Manufacturers will be required to draw up a changeover agreement when changing their UKRP. This agreement would consider the manufacturer, the incoming UKRP and the outgoing UKRP.
Authors notes: Many UKRP’s who currently provide this legal service under the relaxed transitional arrangements may not yet recognize some of their new obligations. Data storage is one such example. UKRP’s 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 stakeholders and these aspects should be considered in company policies, procedures and agreements. You should consider or discuss such aspects as soon as possible.
2. Registration – The MHRA are going to want to see more
Response to Consultation, 4.
The MHRA wants to see greater transparency in its regulation of medical devices in the UK and more traceability of medical devices across the UK. They propose to enhance transparency of information about medical devices by increasing the amount of information they capture and share about devices at the point of device registration.
Authors notes: The MHRA have indicated that they will be asking for more information at the time of device registration (and renewal). Ask yourself whether your technical documentation is currently UKCA compliant and consider whether you have the ability to maintain that documentation throughout the device lifecycle.
You should also ensure that your choice of UKRP is made on the basis of a regulatory partnership. Afterall, they may soon be sharing your product liability. If your UKRP is not a proactive and communicative member of your team and they are not furnishing you with some of the regulatory intelligence outlined in this article then your company and your reputation may be at risk.
You should be confident that your UKRP has the ability to act on your behalf in a priority situation. You can find out how many other clients your UKRP is acting on behalf of on the MHRA public database.
Authors’ closing comments:
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 assesses the ability, expertise and capacity of your appointed /intended UKRP. Have they planned for these changes and what reassurances have they already given to you?
Some UKRP may soon be unwilling or unable to continue their UKRP service because,
· The new regulations will prohibit it
· They do not wish to operate to service with the new liabilities
· They do not have the capacity or expertise (Qualified Person(s))
You do not want to be looking for a new UKRP at a time when industry reaches a pinch point and particularly if manufacturers find their devices ‘orphaned’ by known UKRP’s. Be one step ahead and make sure you are working to your own agenda.
Is your UKRP prepared and equipped to take on the administrative burden of the upcoming changes? There will be a lot of new Agreements to be drafted and signed. New registrations will need to be made with MHRA under UKCA and the MHRA will be asking for more of your information.
Make sure your UKRP has the available expertise and resource to act on your behalf and that they are representing your best interests. Check that your appointed UKRP has experience in direct dialogue with the MHRA.
If you missed Part 1 and Part 2 of these 3 Articles, you can take a look back at the following links:
Strategic Development Director