We recognise the frustration and level of concern of our members on the silence from the MHRA regarding the introduction of the new UKCA mark. Understandably, companies are fearful that their products may be withdrawn from the market from 30 June 2023 for not meeting the new UKCA mark requirements, as a consequence of the lack of time allowed to get the products certified.
Medilink UK and trade associations are in constant dialogue with the MHRA on this matter, ensuring that the concerns of industry are effectively voiced. We continue to push for an extension to the current standstill agreement beyond 30 June 2023, with the CE mark being allowed to continue until the date of the transition provision for a particular device – urging a progressive roll-out of the UKCA mark along the lines of that recently communicated for IVDR. This would allow companies the time to meet the requirements and take some pressure out of the system whilst the appropriate infrastructure would be established e.g., approved bodies.
We are informed that the UKCA report, along with a new schedule for the focus groups involving industry representatives, will be published soon.
We will let you know about any developments as soon as any news comes.