3 Reasons Why using your distributor over a responsible person could damage your Business

Brexit, among other things, has changed the way international manufacturers sell their medical devices in the UK. The Medicines and Healthcare products Regulatory Agency has introduced a UK Responsible Person (UK MDR 2019). A responsible Person has to be a company based in the UK who takes care of all registration of the your products in the UK. Every manufacturer who wants to continue selling their products on the UK market needs this.

One way manufacturers are getting around this is by using their current distributors as their responsible person, I am going to outline why this is not your best option, why using an independent Responsible person is your best, and how it will restrict your business opportunities in the future.

Do you want your technical files to remain confidential

Your distributor will need to hold and have access your propriety information to register your products on the UK market and act as your Responsible Person. Having previous experience of working for a medical device manufacturer I know how important it is to keep this information confidential as the last thing any manufacturer wants is distributor knowing how your products and then taking that to another manufacturer.

Now, you will still need to share your proprietary with an independent Responsible Person company, like UKRepMed, however as we are not a distributor of medical devices and our only interest is looking after the regulatory side of business can ensure confidentiality and security.

Do you still want to be able to switch distributors easily

Most of the time distributors meet sales expectations, However when they don’t you want to be able to have the option of easily changing distributors. If your distributor acts as your responsible person this process will become complicated exercise to terminate any agreement in place.

If you use UKRepMed, allows you to get on with your commercial business without having to consider complex regulatory issues

Do you want the option of having more than one distributor in the UK?

As a manufacturer you want to be able to have much as access to markets as possible and this could mean having more than one distributor in the UK in the future or you may have more than one now.

Whoever your responsible person is going to be they will be put visibly on your product labels. This could put potential distributors off as they will have a competitor on their products.

With UKRepMed this will not be a problem and you will maintain your brand image in all European markets