Clarity Pharma (‘Clarity’), a prominent UK consultancy, market access and logistics partner to the medical and pharmaceutical sectors, is urging medical device manufacturers to act now with time running out to complete their conformity checks and register Class I products before a government grace period ends on January 1, 2022.
Legislation, which regulates how medical devices are placed on to the UK market, was introduced by the UK Medicines and Healthcare Regulatory Agency (MHRA) on January 1, 2021. The new rules applied to all medical devices, including in vitro diagnostic medical devices and active implantable medical devices. However, the regulatory body offered grace periods extending throughout this year for different classes of device to enable manufacturers to implement new procedures and ensure compliance.
Enforcement relating to class 1 medical devices, such as thermometers, pregnancy tests and throat sprays, from January 1, 2022, signals the end of all grace periods and means products must be registered with MHRA before they can be placed onto the UK market, under their existing CE Mark or Certification.
This is a key step to continuing supply within the UK market ahead of all Medical Devices needing to migrate to UKCA by July 2023.
Max Trebilcock, UK Medical Device Responsible Person at Clarity, commented: “Companies have had 15 months to prepare for this legislation but of course, the challenge of day-to-day business means such things can easily slip under the radar. It’s not too late to take action now to ensure you can meet your future obligations.
“With such an important – and potentially costly – change on the horizon, Clarity Pharma can support manufacturers and advise on compliance and the MHRA legislation. We are keen to ensure the introduction of the new regulations is smooth and efficient for companies.”
Devices only have to be certified and registered with the MHRA where the manufacturer’s place of business is in the UK. Manufacturers based outside of the UK, wishing to place a device on the market in Great Britain, need to appoint a single UK Responsible Person who will take responsibility for the product. Those based in Northern Ireland, who have registered their device with the MHRA for the purposes of Northern Ireland, and free flow with Britain, will not have to undergo any further registration in Great Britain.
Marcus Sanders, executive director added: “Clarity Pharma can offer expertise in the global pharma market and help manufacturers understand their obligations wherever they are based or the geographies they operate within. Our team of regulatory and compliance experts can assist businesses with the testing of products, as well as the completion and submission of documentation to the relevant authorities. Ultimately, we can simplify the complex and help companies save time, ensure accuracy, all while delivering complete peace of mind.”