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Medical Device Reclassifications or Up-Classifications: Devices that Currently do not Require a CE certificate

There are several devices that currently do not require a CE certificate under the Directives, which will need certification under the EU MDR by 26 May 2020 for continued market access. This may be due to up-classifications (e.g. some software that is currently Class I under MDD but are Class IIa or higher under MDR) or due to changes in the scope of the legislation (e.g. devices that contain non-viable derivatives of human tissues or cells, which are covered by MDR, but outside the scope of current device directives).

If you have any such devices within your portfolio and need assistance in upgrading your files and submission to your notified body, please do not hesitate to contact us.

Email: info@advenamedical.com

Medical Device Regulation (MDR) EU Regulation – Class I Reusable Surgical Instruments

Manufacturers of Class I Reusable Surgical Instruments must now obtain a CE certificate under Annex IX Chapters I & III or Annex XI – Part A (limited to the re-usability aspects, as appropriate) by no later than May 26th, 2020 for these devices.

Failure to do so will exclude them from placing these devices on the EU market from May 26th, 2020 onwards or until you achieve CE certification.

To be clear your current medical device registration (MDD) will become invalid on May 25th, 2020. You must act now if you wish to continue to CE mark and supply these devices.

Remember, while Notified Body CE certification is limited to the aspects concerning the reusability of your devices, all your technical documentation must also be upgraded to comply with the MDR and Advena can assist with the technical file upgrades.

Time is now running out and there are only two Notified Bodies currently designated to MDR (BSI UK & TUV SUD). The EU Commission have promised that more will be available by the end of the year, therefore, it makes sense to begin the process of upgrading your technical documentation/files now. So, you need to instruct your regulatory team to begin preparations, if you don’t have the resources internally please do not hesitate to contact us, as mentioned above, we can help!

Email: info@advenamedical.com

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

Meet Advena in Miami at FIME 2019

Advena are exhibiting at FIME 2019, this trade fair is considered one of the most important across the Americas and is taking place at the Miami Beach Convention Center in Florida.

Advena will be located at booth B45 in the gold zone, at this important show in Miami from 26th to 28th June 2019.

We will be available to meet existing and prospective clients during this trade show.

Attending on behalf of Advena Ltd., is the Managing Director from our Maltese office, Anthony Kirby. It would be fantastic to connect with any of our clients who plan to visit this important Americas trade show, so please do stop by our booth or contact us for an appointment;

Email: info@advenamedical.com

Further details about FIME 2019 may be found at this link

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 info@advenamedical.com

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