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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 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

 

Meet Advena at Arab Health 2019

Advena will be located in Za’abeel Hall 4, Stand Z4 J43 at this important show in Dubai from 28th to 31st January 2019.

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

We advise those who would like to meet one of our team to email for an appointment (info@advenamedical.com) well in advance to ensure we are available.

At this show the following Advena team members will be in attendance:

Anthony Kirby: Managing Director (Advena Malta)

Kirsty Ostle: Managing Director (Advena UK)

Kenneth Shaw: Regulatory Consultant (Advena Malta)

 

If you are planning to visit Advena at Arab Health please order your visitor pass now to secure your free pass and avoid the on-site registration fee. To register visit this link

Further details about Arab Health 2019 may be found at this link

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/

Software as a Medical Device

Software within the healthcare industry is exploding with innovation so much so that regulation is only now starting to catch up!, making software key to a medical device revolution. Software is now incorporated within many medical devices including smartphones. This means that such software and applications must abide by the relevant EU legislation and must obtain a CE mark before placing on the market.

Software as a Medical device is a piece of software which is intended to be used for one or more medical purposes. Software that performs these purposes without being part of the medical device is known as Stand Alone Software classified as an “Active Medical Device”.

One must also consider the case in which the software is incorporated into the medical device, driving and/or influencing its behaviour. In this case, the software shall fall into the same classification as the device itself.

In some cases Software may be a borderline medical devices which can make it difficult to determine its classification. At Advena, we have the necessary experience to determine the correct classification of your software based on its description and intended use, as well as build the EU compliant technical documentation which you will require to obtain the CE mark.

For further information on how we can help get your software on to the EU market, please contact us on info@advenamedical.com.

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