IVDR Transition and Notified Bodies…… Early engagement is still critical!
If you are currently providing a UKRP service or if you are an Ex-UK Medical Device or IVD manufacturer who requires the services of a UKRP, you should consider the following information very carefully.
This is the 2nd 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.
1. Qualified Person (named person(s)
Response to Consultation, 12.2, 14.2
The government intends to introduce a requirement for UKRPs to have at least one Qualified Person permanently and continuously at their disposal. The Qualified Person(s) will be required to have qualifications or regulatory experience that exceeds minimum standards (which will be sent out in the Regulations). The government will also consider and provide clarity in guidance around capacity and terminology.
Action –Make sure that you have appointed a UKRP who has available capacity and is planning to have at least one Qualified Person permanently and continuously available to them. Look for reassurances that there will be no expected capacity issues surrounding the future named person(s), in case the Government decide to define this particular aspect
Authors notes: Whilst we don’t yet know what the minimum qualifications or regulatory experience will look like, we can only trust the Government’s intention to align with EU Regulations and international standards and therefore we may look to MDR and IVDR – Article 15 for a sense of what to expect.
Although we must wait until the Government provides further clarity around this role, you can still check the capacity and ability of your UKRP. Ask those questions in the interest of protecting your business and ask whether that service provider intends to continue offering that legal service after the new Regulations have been laid down. Perhaps it’s time to get those reassurance in writing.
Response to Consultation, 12.2,
It is the intention of the UK Government to clarify that the UKRP will be legally liable (responsible or answerable in law) for defective medical devices on the same basis as the manufacturer.
Action – Make sure you have appointed a UKRP who does or who intendeds to hold appropriate liability insurance. You will need proof.
Authors notes: We live in litigious times, meanwhile medical devices and IVD’s can sometimes provide unique or challenging proposition for underwriters. Emerging risk and issues with similar technologies can also impact the way that an underwriter may view the risk of potential harm resulting from use (or potential misuse) of your device(s).
You should also consider wider factors such as cyber risk, hacking and compromised privacy data. These too may also change the way Medtech insurers calculate the cost of protection against the potential for patient harm.
Under the changes indicated by UK Government, your appointed UKRP will be required to take out professional indemnity insurance to act on your behalf and you may now expect this to be presented as a pass-through cost. Make sure you have budgeted for this change.
In part 3 (Friday), we will take a quick look at Agreements, new registration requirements and I will then sum up with closing thoughts and comments.
If you missed Part 1 of 3 (yesterday), you can take a look back at the following link:
Director of Consulting Services