While it has been nearly two years since the UK withdrew from the European Union, much still remains uncertain about the direction that the Medicines and Healthcare product Regulatory Agency (MHRA) will take with its requirements. Will change happen, and if so when? It’s a bit of a baptism by fire with the regulators only letting companies know when they actually do something wrong.
On a positive note, the MHRA has decided to continue to follow the Medical Devices Directive rather than move to the new Medical Devices Regulation, or similar, for the time being. That at least means there isn’t another set of changes for companies to consider.
“Companies remain uncertain which direction the MHRA will go in and when changes will occur.”
Parallel systems
However, it does mean companies will have to have parallel systems to manage their products in the EU and in the UK. Companies that have gone to the effort to put in place processes to comply with the MDR will have to take a bit of a step back when submitting or managing their products in the UK. It also means having a different Notified Body for their UK products compared with their EU products, as well as changes to their technical files to refer to UK, as opposed to EU, regulations. All of this is going to be difficult to manage.
Compounding that, in Northern Ireland there is a different protocol in place to prevent checks along the border between Northern Ireland and the Republic of Ireland. What it means is Northern Ireland is implementing the MDR alongside the EU while being aligned with the UK, which also means having to comply and register all the devices with the MHRA. This is still a very contentious issue, and much remains unclear, which leaves manufacturers in a quandary as they try to delve through all these different regulations and what’s required. Yet, all they want to do is sell their products.
A learning curve
The differences posed by Brexit have a particular impact on the EU authorised representative and the comparable UK responsible person. The chart below illustrates the similarities and differences. Brexit is a learning curve for everyone. We are hopeful that the coming months will result in greater clarity for companies.
Responsibilities for the UK Responsible Person and the EU Authorised Representative
| Responsibility | EU Authorised Representative | UK Responsible Person |
| Ensure Declaration of conformity has been appropriately assessed | Yes | Yes |
| Keep on file current version of technical file | Yes | Yes |
| Act as contact for manufacture to regulatory agency | Yes | Yes |
| Provide all requested information to regulatory agency, as requested | Yes | Yes |
| Comply with request from regulatory agency to provide access to the device | Yes | Yes |
| Cooperate with regulatory agency on preventative & corrective actions to be taken in relation to the device | Yes | Yes |
| Inform regulatory agency of any complaints or reports from healthcare professionals, patients and device users of incidents | Yes | Yes |
| Terminate relationship with manufacturer should non-compliance issue warrant such action | Yes | Yes |
| Provide name of representative on device label | Yes | Yes |
| Register device with regulatory authority | Yes (EUDAMED) | Yes (DORS) |
| Advise manufacturer of changes to relevant laws that may affect marketability of device | Yes | No |
| Liable for defective devices with manufacturer if manufacturer is non-compliant with regulations | Yes | No |
| Continuous access to a person responsible for regulatory compliance | Yes | No |
About the author:
Deirdre Harrington, Representative Services and Quality Manager at IDEA Regulatory, Dublin, is a Clinical Operations professional with a strong background in science combined with 20 years of experience in the device, pharmaceutical and biotechnology industries. Deirdre has broad experience with clinical research projects complying with ICH, FDA 21 CFR, EU GxPs and legislation, across a wide range of therapeutic areas.