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Advena Limited – Statement on COVID-19

The COVID-19 pandemic is rapidly affecting lives and how businesses operate worldwide. Increasingly governments are introducing stricter measures to protect public health, which ultimately impacts on the movement of Advena Limited’s employees’, the individuals we trust to implement our regulatory obligations.

During these difficult times the safety and well-being of our families, friends and colleagues are our highest priority.

Advena Ltd a leading EU Authorised Representative and provider of regulatory & QMS consultancy in the medical devices industry are committed in their support of this important industry and in the part played in assisting the availability of health care products for the EU market. However, we must also comply with any restrictions applied by both the Maltese and UK governments and also implement our own COVID-19 pandemic crisis plans based on the further recommendation given, e.g. protection of employees at high-risk and working remotely, including quarantine and social distancing. These measures will undoubtedly provide challenging circumstances; however, we remain resolute in our ability to continue to meet our obligations to regulation and clients.

Therefore, while our service may experience some delays, we do not expect to suspend operations, temporarily or otherwise.

During this difficult period in our history we ask that you be patient and bear with us and above all stay safe.

Come and Visit Advena at Arab Health 2020

At this year’s event both Advena Limited (UK) Advena Limited (Malta) will be represented. We will be located in Hall 2 Stand G15 within the UK pavilion, at this important show in Dubai from 27th to 30th January 2020.

Please do come and visit to discuss your medical device regulatory needs, whether this be our EU Authorised Representative service (EC REP) or our QMS & Regulatory Medical Device Consultancy services and how Brexit, the MDR or IVDR may affect your business and regulatory compliance activities.

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

Kenneth Shaw: Regulatory Consultant

If you are planning to visit Advena at Arab Health, please order your visitor pass now to secure your free pass. To register visit this link

Further details about Arab Health 2020 may be found at this link

 

UDI Issuing Entities

In early June, the European Commission (EC) announced the four issuing entities for the Unique Device Identifier (UDI): GS1, the Health Industry Business Communications Council (HIBCC), ICCBA Informationsstelle für Arzneispezialitäten (IFA GmbH). The decision was made with the help of the Medical Device Coordination Group (MDCG) after the four companies were found to meet all the relevant criteria.

Click here for a copy for the Commission Implementing Decision (EU) 2019/939

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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