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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 Update

It would have been difficult to miss the recent news (certainly if you’re based in Europe) regarding the UK Government’s delivery of the letter to the EU Commission, invoking Article 50 of the Lisbon Treaty, where a member state officially notifies of its intention to leave the EU, and so the negotiation process begins.

So what does this mean for non-European manufacturer’s looking for an EU Authorised Representative (EC REP)?

In reality nothing has changed right now, however in the future, perhaps within 2 years it may be that UK based organisations can no-longer offer an EU Authorised Representative service. Potentially causing a certain amount of regulatory chaos, and clearly bad news all round for the medical device industry.

How will this affect Advena and our clients?

We are in what may be described as the perfect position, where we can assure our clients it is “business as usual” even though we are unable to ignore the possibility of an effect on medical device companies who wish to CE mark medical devices and sell throughout the EU. Advena are in the enviable position of being able to continue as an EU Authorised Representative business with offices based in the UK and in Malta and therefore, whatever the outcome of the UK’s negotiations with the EU, Advena will be here to assist and advise its clients (new and existing) regarding regulatory matters and EU medical device registrations. Another positive for our two operational locations is both acknowledge English as an official language.

Furthermore, UK medical device manufacturers may, in the future, require the services of an Authorised Representative to gain access to the EU market, while the EU and the rest of the world’s medical device manufacturers may need an Authorised Representative to gain access to the UK market, again we are in the perfect position, remember we, Advena, are based in the UK and in the EU, Malta.

There is a long and difficult path ahead for the UK and the EU, the negotiation process will not be easy or straightforward. However for medical device manufacturers who need an Authorised Representative the choice has been made a little simpler, choose Advena!

For more information please email info@advenamedical.com

Lithium batteries and Medical Devices in the EU

The safety of battery operated devices is attracting increasingly stringent scrutiny and it has been determined that, as from 1 May 2012, all lithium-ion batteries must be tested and certified to the standard IEC 62133. The exceptions are for information technology equipment (standard IEC 60950-1 applies) and audio/video devices where IEC 60065 applies.

This includes all batteries and battery packs intended for use in conjunction with medical products which must be evaluated and certified accordingly. (This would normally be undertaken and certified by the battery manufacturer / supplier.)

A supplier’s pre-certification to IEC 62133 will assist to assure that the legally required and applicable Medical Device Directive essential requirements may be answered , in particular essential requirement 9.3:

9.3 Devices must be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances which could cause combustion.

This will then relate to the way the a medical device manufacturer may demonstrate that hazards from using such batteries in their device(s) have been risk assessed to the EU harmonised and essential standard EN ISO 14771; 2012. By undertaking such a risk study, as part of the Technical File, it should be demonstrated that the device is:

  1. Inherent safety by design
  2. Protective measures in the actual medical device and/or manufacturing process
  3. Information for safety, such as labeling and instructions for use

If the battery is incorporated within a device then the whole device, including the actual battery and charging circuits, should conform to EN ISO 60601-1 which covers basic safety and essential performance for all Medical Electrical Equipment.

With the spread of wireless and mobile technology, electromagnetic disturbances arise which can affect medical equipment and prevent it from working in the way it was intended to. Therefore it is also essential that such medical equipment is not oversensitive to radio frequency interference and in addition electromagnetic emissions from it should not interfere with other equipment and systems. Essentially this means testing and certifying to

BS EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

Before any electrically powered device will be accepted in a clinical or hospitals environment it would be expect it to be certified accordingly before they would purchase.

Prepared for Brexit: Advena in the news

The Business Desk West Midlands

“Warwick firm adopts Maltese registration to improve EU trading”

http://www.thebusinessdesk.com/westmidlands/news/739349-warwick-firm-adopts-maltese-registration-to-improve-eu-trading.html

Coventry Telegraph

“Advena Limited is based in Warwick and will retain all of its operations in the UK, but has set-up an office in Malta where the business is now registered as a subsidiary.”

http://www.coventrytelegraph.net/news/business/brexit-forces-warwickshire-business-move-11832211

Advena are prepared, by active leadership from our dual locations, to assist medical device and cosmetics manufacturers wherever they are to practically and efficiently work through any political eventuality that the UK’s vote to leave the EU may inspire. For further details please see our Brexit Information Portal >

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