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UKCA: UK’s Proposed ‘CE Mark’ Replacement

In February 2019, the MHRA published guidance on the use of the ‘UKCA’ (UK Conformity Assessed) mark in the event of a ‘No-Deal’ Brexit. The guidance stated that the UKCA mark would not be recognised on the EU market and manufacturers would still be required to obtain CE marking for products to be placed on the EU market and that the UKCA mark will need to be applied in the following situation(s);

  • The product is for the UK market.
  • The product requires mandatory third-party conformity assessment.
  • The conformity assessment for the product has been carried out by a UK conformity assessment body (a UK-based notified body or recognised third-party organisations).

The guidance also stipulates that “in the majority of cases you will still be able to use the CE marking if you are selling goods on the UK market after the UK leaves the EU. The CE marking will only be accepted in the UK for a limited time after Brexit”, however, this guidance was withdrawn on 30th January 2020.

With the deadline for the end of the 1-year transition period fast approaching, it is still unclear whether the UK government intends to put these measures in place. As a result, manufacturers are urging the UK government to provide more details and guidance on these plans to ensure they have adequate time to prepare to affix the UKCA mark on their products.

It is understood that the UK government is not likely to announce details of the new UKCA mark until a mutual decision has been made as part of the ongoing UK-EU trade negotiations. Understandably, concerns are growing as to the relatively short time left to put any new UK requirements in place to ensure compliance before the end of the year, although we have been made aware from a reliable source that the MHRA is currently reviewing the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

We will keep you posted with any updates as soon as we receive them.

BREXIT UPDATE! UK & Non-UK Based Medical Device Manufacturers

As many of you will now know, the Conservative & Unionist Party have elected a new leader in Boris Johnson, who has also become the UK’s new Prime Minister.

The new Prime Minister has clearly laid out his plans for the timetable of Brexit, in as much as that he and his team of cabinet ministers now speak with one voice, that the UK will leave the EU,  on or before the 31st October 2019, either with an improved deal or on a no deal basis.

The EU have stated, that they do not want the UK to leave without a deal but will not renegotiate the deal that has been offered. The UK’s new Prime Minister and his team does not accept the EU’s deal and prefers not to leave without a deal, however, and crucially are prepared to exit the EU without a deal.

This situation makes it increasingly likely that the UK will leave the EU on the 31st October 2019 without a deal.

So, what does this mean for UK medical device manufacturers?

Obviously, the key date to consider is the 31st October 2019, after this date UK based device manufacturers may no-longer be permitted to legally place product on the EU market without appointing an EU Authorised Representative (EC Rep).

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 on the 31st October 2019 (and this is now the most likely outcome) the implementation period is removed, the EU will not provide a transition period, meaning that UK device manufacturers will almost certainly 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.

Equally all manufacturers based outside the UK wishing to continue to market within the UK after a no-deal Brexit, must be aware of the new requirement for a dedicated UK Responsible Person (UK RP). The UK RP would be responsible for performing registrations with the MHRA. We provided some guidance back in February and again in March which suggested that Advena Ltd UK will be able to offer this service.

Therefore, October 31st, 2019 will be a critical date!

We strongly recommend both UK based, and non-UK based medical device manufacturers contact Advena to discuss the options available to them. We are uniquely based in the UK and in Malta, where we offer our EU Authorised Representative service from Malta, the UK Responsible Person service from the UK and a full range of medical device regulatory and QMS consultancy services from both offices, therefore a local UK/EU service to help maintain both EU and UK 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.

Please contact our team for more details: info@advenamedical.com

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!

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