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MDR ARTICLE 120(3) TERMS AND CONDITIONS

It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions:

From 26 May 2020:

  • The device continues to comply with the Directive.
  • There are no significant* changes in the design or intended purpose.

Furthermore, the requirements in the MDR related to the following shall apply:

  • Post-Market Surveillance [Article 83-86, 92, Annex III]
  • Market Surveillance [Article 93-100]
  • [Article 87-92]
  • Registration of economic operators and devices [Article 31 and 29]

* The MDCG have produced guidance on significant changes, please see this link.

Whether a change in design or intended purpose may be considered as significant shall be determined on a case by case basis, however, the following changes shall not be considered to be significant:

  • Reductions or limitations of the intended purpose.
  • Design changes related to corrective actions assessed and accepted by the Competent Authority.

The Notified Body who has issued the AIMDD/MDD certificate shall continue to be responsible for the surveillance relating to the devices it has certified.

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

ISO 13485:2016 Success For Advena Ltd in Malta!

Advena Limited,  Malta have chalked up a remarkable success!

Following the successful re-certification audit at our UK office at the end of February 2019, the next task was to audit our office in Malta (an EU27 member state) for inclusion on our ISO 13485:2016 certification. Advena’s experts set about this tricky task providing carefully planned advice and guidance to our Maltese team, the result of which, after a gruelling audit by LRQA, one of the UK’s most respected Notified Bodies, was a glowing report and more importantly achieving the much converted certification it needed to move its EU Authorised Representative (EC REP) business forward.

If you’re looking for an EC REP based in the EU27 or are looking for QMS consultancy to ISO 13485:2016 please contact us for more details and become part of a success story.

Email Advena: 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.

Meet Advena at MEDICA 2018

It’s that time of the year, MEDICA 2018 is almost upon us. This year two members of our team will be visiting this important exhibition in Düsseldorf.

We encourage both new and existing clients to take the opportunity to meet us to discuss your regulatory needs. To avoid disappointment please email in advance to arrange an appointment at a convenient time.

Dr. Andrew Whitton
Senior Regulatory Consultant
andrew.whitton@advenamedical.com
Richard Bassett
Senior Regulatory Consultant
richard.bassett@advenamedical.com

For more information regarding MEDICA https://www.medica-tradefair.com/

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