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UK Responsible Person

A publication released by the MHRA on the 4th January, updated on the 26th February explains how the UK will regulate all medical devices under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). Whilst all those devices currently CE marked before the 29th March 2019 under one of these directives will continue to be recognised by the UK for a ‘time-limited period’, one of their criteria is the introduction of a UK Responsible Person for those device manufacturers not established in the UK.

‘Where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a ‘UK Responsible Person’ established in the UK and with a UK registered address who will take responsibility for the product in the UK. No labelling changes will be required to reflect the role of this ‘UK Responsible Person’.

The UK Responsible Person will be responsible for ensuring all devices are registered with the MHRA prior to being placed on the UK market. A grace period for registration has been allowed for compliance with the new registration process. The timings are set out as:

4 months, for Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, IVD List A and procedure packs that contain any of these devices.

8 months, for Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B, Self-test IVDs.

12 months, for Class I medical devices, Self-certified IVDs, Class A IVDs.

The publication then goes onto explain that initially the MHRA will require most products to be registered at the level of Global Medical Device Nomenclature (GMDN) code meaning that groups of similar products can come under a single registration. The exception is class III devices, which must have individual product information registered.

Once the MDR and IVDR fully apply (from May 2020 and May 2022 respectively), the UK will then mirror the new requirements within the legislation, which will mean individual registration of all products

Advena are as usual able to assist all EU (non-UK) and Non-EU device manufacturers to provide a UK Responsible Person  via our new ‘UK Responsible Person Service’. Registrations will be performed by our UK office.

Please contact our UK administration team for more information at

Brexit and UK Medical Device Manufacturers Access to the EU Market.

Even now after the draft text of the withdrawal agreement has been agreed by Government, there remains considerable uncertainty regarding the commercial impact of Brexit and how this will affect UK based medical device manufacturers who CE mark devices.

As we have done over the last 2 years, we at Advena track UK political news closely and it seems as if UK device manufacturers will eventually need to appoint an EU Authorised Representative (EC REP) and label their devices with their address. This EC Rep must have a physical place of business in the EU27.

The key date to consider is the 29th March 2019, after this date UK based device manufactures may no-longer be permitted to legally place product on the market without appointing an EC Rep. (click here).

If a deal is struck between the EU and the UK the implementation period that has already been agreed allows UK manufacturers until December 2020 to appoint an EC Rep and update your information and materials, including, but not limited to, packaging, product labels, IFU’s, brochures, CE Certificate, and Declarations of Conformity where you can be expected to indicate the name and address of your EC Rep.

However, if the UK crashes out of the EU without a deal, and this is still a definite possibility the implementation period is removed and the EU have not made a commitment to provide a transition period, meaning that UK device manufacturers could potentially be locked out of the EU until such time that they have appointed an EC Rep, updated device registrations and their information and materials as mentioned above. Therefore the 29th March 2019 could be a critical date!

We strongly recommend UK based medical device manufacturers contact Advena to discuss the options available to them. We are uniquely based in the UK and in Malta, we offer our EU Authorised Representative service from Malta, but also have offices in the UK, therefore offering a local service while guaranteeing EU market access. And of course we are English speaking as is our team in Malta.

With over 20 years’ experience as a provider of regulatory services we have a wealth of knowledge that you can benefit from.

Brexit and Access to the EU Market for Medical Devices

There is considerable uncertainty regarding the commercial impact of Brexit and how this will affect medical device manufacturers who CE mark devices and use a UK based EU Authorised Representative (EC REP) and label their devices with a UK address.

Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster, a “hard” Brexit may be almost inevitable.

The key date at the moment is the 29th March 2019, after this date UK based EC REP’s may no-longer be permitted to legally act as an Authorised Representative to a non-EU manufacturer (click here).

Notified Bodies have already been suggesting that manufacturers look for an alternative EC REP who is based in one of the other 27 EU member states.

This negative news is further emphasised by the fact that UK Notified Bodies have now assured that they have their own EU operational addresses outside the UK so they may continue their certification business.

For Advena Ltd, and our non-EU clients, the good news is Brexit carries very little risk as we have two EU locations, one in the UK and the other in Malta.

Therefore in the event of a ‘hard’ Brexit Advena’s clients will be transferred to our Maltese office and self-declared registrations will similarly be transferred.

We strongly recommend any non-EU manufacturer of medical devices who currently use a UK based EU Authorised Representative (EC REP) contact Advena to discuss changing from your current service provider to Advena in Malta and benefit from our 20 year’s experience as a provider of medical device regulatory services.

As a valued Advena client EU market access is guaranteed.

Contact our team if you want to know more and stop worrying about Brexit!

Brexit and the UK Medical Device Industry

There has been a lot of uncertainly about how Brexit is going to affect medical device manufacturers in the UK.

Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster a “hard” Brexit may be almost inevitable.

This is emphasised by the UK Notified Bodies silently assuring they have an EU base so they may continue certifications.

For our non-EU clients this is no problem, we will change AR address and registrations to our Malta office but for those based in the UK there could be little alternative than to assign an EU Authorised Representative (with an EU office, such as ourselves) for label references and any applicable registrations so the CE marking may continue.

For a UK manufacturer to have to contract with an Authorised Representative consultancy in mainland Europe, with all the currency and associated language issues, may seem like a bridge too far when viewed alongside all the other regulatory changes on the horizon.

However, we at Advena thought about this possible outcome almost 2 years ago and now, with our established and manned office in Malta, we are able to offer a smooth transition without changing our administration and English language communication base in the UK.

For any EU medical device manufacturers concerned about this possible impact they should contact us now so we can offer a “pre-mandate” ready for such an eventuality at 30% off our standard AR fees for the first year. No invoice would then be raised until political necessity arises and a swift change over to the Maltese address, and any accompanying registrations can be made.

Contact our team if you want to know more and stop worrying about Brexit!

Brexit Update

It would have been difficult to miss the recent news (certainly if you’re based in Europe) regarding the UK Government’s delivery of the letter to the EU Commission, invoking Article 50 of the Lisbon Treaty, where a member state officially notifies of its intention to leave the EU, and so the negotiation process begins.

So what does this mean for non-European manufacturer’s looking for an EU Authorised Representative (EC REP)?

In reality nothing has changed right now, however in the future, perhaps within 2 years it may be that UK based organisations can no-longer offer an EU Authorised Representative service. Potentially causing a certain amount of regulatory chaos, and clearly bad news all round for the medical device industry.

How will this affect Advena and our clients?

We are in what may be described as the perfect position, where we can assure our clients it is “business as usual” even though we are unable to ignore the possibility of an effect on medical device companies who wish to CE mark medical devices and sell throughout the EU. Advena are in the enviable position of being able to continue as an EU Authorised Representative business with offices based in the UK and in Malta and therefore, whatever the outcome of the UK’s negotiations with the EU, Advena will be here to assist and advise its clients (new and existing) regarding regulatory matters and EU medical device registrations. Another positive for our two operational locations is both acknowledge English as an official language.

Furthermore, UK medical device manufacturers may, in the future, require the services of an Authorised Representative to gain access to the EU market, while the EU and the rest of the world’s medical device manufacturers may need an Authorised Representative to gain access to the UK market, again we are in the perfect position, remember we, Advena, are based in the UK and in the EU, Malta.

There is a long and difficult path ahead for the UK and the EU, the negotiation process will not be easy or straightforward. However for medical device manufacturers who need an Authorised Representative the choice has been made a little simpler, choose Advena!

For more information please email

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