BEO BERLIN wurde oft nach zuverlässigen Lösungen für die Bereitstellung eines UK REP gefragt. Es gibt im Internet viele Anbieter*innen und es besteht auch die Möglichkeit die Vertriebspartner*innen entsprechend zu verpflichten. Letzteres ist jedoch nur eingeschränkt und mit Vorsicht und nach genauer Prüfung der Interessen ein empfehlenswerter Weg. UK RepMed Ltd, a company that is authorised for this activity and has the relevant experience, has this to say:
Der Brexit hat die Art und Weise geändert, wie internationale Hersteller*innen ihre Medical Devices n the UK. The „Medicines and Healthcare products Regulatory Agency“ (MHRA) verlangt nun von einem*r Hersteller*in, dass er eine Verantwortliche Person im Vereinigten Königreich hat („Responsible Person“ UK MDR 2019). A Responsible Person must be a separate company based in the UK acting on behalf of the manufacturer. Manufacturers outside the UK who wish to sell or continue to sell their products on the UK market must appoint a Responsible Person. Some manufacturers use their current distributors as the Responsible Person. Whilst this is a quick approach, it could mean that your business potential in the UK is compromised.
Here are 3 reasons why appointing a distributor instead of an independent Responsible Person could be detrimental to your business:
Do you want your technical documentation to remain confidential?
Your distributor must have and have access to your proprietary information in order to register your products on the UK market and act as a Responsible Person. As UK RepMed already works for medical device manufacturers, we recognise the importance of keeping this information confidential.
UK RepMed is an independent specialist company, so confidentiality and security are assured.
Do you still want to be able to switch distributors easily?
Many distributors fulfil sales expectations. However, if they do not fulfil them, you want to be able to easily switch to a new sales partner. If your sales partner is acting as your responsible person, this process becomes complicated if you need to deregister them and appoint another. Furthermore, this could disrupt your existing business.
UK RepMed allows you to focus on your business objectives without having to deal with complex regulatory issues.
Would you like to have the option of having more than one distributor in the UK?
As a manufacturer, you want to maximise your sales potential in the UK market. This could mean having more than one distributor. Labelling one distributor as the responsible person on the product label could prevent other distributors from working with you.
With UK RepMed, this conflict is not a problem and you can maintain your brand image in all markets.
BEO BERLIN has found a provider in UK RepMed Ltd that has everything we consider necessary in terms of expertise, reliability and legal validation.
Contact us, we would be happy to discuss your situation and help you make the right decision.
Source: UK RepMed
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