Our United Kingdom Responsible Service
With United Kingdom’s leave of European Union via Brexit, new regulations that the manufacturers are required to comply has emerged. As a requirement of these regulations, from now on, for some sector manufacturers who export to UK but not located there, it is not possible to have their products registered Competent Authority United Kingdom and enter the UK market unless they have an assigned United Kingdom Responsible Person. Medical Device and IVD sectors are also among the sectors which is subject to these regulations. The scope of the registration requirement which was initiated with active implantable medical devices on May 1st 2021 will gradually be expanded to cover Class 1 medical devices by January 1st 2022.
The duties of United Kingdom Responsible Person, who can either be a real person or an entity, are very similar to European Union Authorized Representative. Regarding the manufacturers obligations that arise out of UK Medical Devices Regulations 2002, the United Kingdom Responsible Person in the UK acts on behalf of the manufacturer. One manufacturing firm can be represented by only one United Kingdom Responsible Person. This person must be physically present in the UK and for the issues related to the manufacturer, he is the point of contact. For the products of the manufacturer, as required by the new regulations, on behalf of the manufacturer, this person fulfills the requirements such as preparation the declaration of conformity, technical documentation and conformity evaluation and he responds information request of Secretary of State regarding the risks associated with the products and other issues, and runs the related procedures. Whenever an amendment is made on the products, the United Kingdom Responsible Person notifies the UK Competent Authority. On the other hand, whenever an adversity associated with the products of the manufacturer is observed, United Kingdom Responsible Person will again be the primary interlocutor of the British Government.
Currently in UK, in general, consultancy firms that are not related to medical sector are providing services to foreign companies and these services are limited with product registration.
If you are also operating in the sectors of Medical Device or IVD, and if you are already exporting or planning to export to United Kingdom, with the purpose of fully responding to this critical need which arise out of new regulations introduced, as Zeela having 13 years of medical sector experience and our strong team, we will be happy to represent you in the United Kingdom as “United Kingdom Responsible Person”.
In addition to our representation services, for those manufacturers who wish to participate in the tenders in UK with us, we are providing support in the areas of tender preparation and follow up, all free of charge.
Best Price Guarantee
Our company which aims to deliver the best service with the most competitive price, avoids implementing the pricing policy that is observed in nearly all of the service providers of this type, which is pricing per product. The representation fee of the Zeela is determined irrespective of the number of products, but per manufacturer register. According to that, whatever the number of products you export to United Kingdom, as you are one manufacturer, you will pay a single fixed fee to Zeela and all your registration services will be completed within 5 business days.
Zeela also guarantees the best price in its sector. There, for the services of United Kingdom Responsible Person or product registry, if after agreeing with us and start working together you identify an official offer for the same service in the market, Zeela guarantees to reduce its price to that lower level.