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Another Advena Success!

Following an intense 3 day ISO13485 transition audit we are pleased to announce Advena Limited & Advena Medical Limited have been recommended for ISO13485:2016 certification.

This remarkable achievement is all the more impressive as it included a transfer from BSI to LRQA. Underpinning our ability to offer QMS consultancy to medical device manufacturers worldwide.

If you are looking to introduce a quality management system or to transition to ISO13485:2016 and need advice and consultancy please do contact us we have a team of experts ready to help!

Using Distributors and Importers as an EC REP and Data Security.

Over the years we have expanded our comprehensive European Authorised Representative services to many non-EU manufacturers who have traditionally used EU importers and distributors for this role.  Now, and particularly with the new EU device regulations looming that require data sharing, perhaps the time may be now to ask the question;   “Can you trust your importer or distributor with your intellectual property”?

This is an especially critical issue for new and innovative technology. Advena already operates a best practice approach treating client data as confidential, to reinforce this we encourage the use of non-discloser agreements, whereas others such as distributors may not always act in the manufacturers best interests and therefore, may not be so diligent.

When a device manufacturer works with Advena all confidential documents, manuals, certificates, dossiers and project related files are only stored on our secure password protected server that is accessible only to employees who are subject to stringent confidential agreements.

Client confidential data would never be archived on laptop computers that could be lost or stolen.

The new medical device regulation (MDR) stipulates that the manufacturer shall in order to allow its Authorised Representative to fulfil its tasks ensure that the necessary documentation is permanently available. This will be very important in the future where EU Authorised Representatives will be legally required to be able to access manufacturer’s compliance data.

So the question is, do you really want your distributor or importer to have permanent access to your sensitive technical data?

If you currently use a distributor or importer as your EU Authorised Representative, this is a subject worth some serious consideration.

Brexit and the UK Medical Device Industry

There has been a lot of uncertainly about how Brexit is going to affect medical device manufacturers in the UK.

Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster a “hard” Brexit may be almost inevitable.

This is emphasised by the UK Notified Bodies silently assuring they have an EU base so they may continue certifications.

For our non-EU clients this is no problem, we will change AR address and registrations to our Malta office but for those based in the UK there could be little alternative than to assign an EU Authorised Representative (with an EU office, such as ourselves) for label references and any applicable registrations so the CE marking may continue.

For a UK manufacturer to have to contract with an Authorised Representative consultancy in mainland Europe, with all the currency and associated language issues, may seem like a bridge too far when viewed alongside all the other regulatory changes on the horizon.

However, we at Advena thought about this possible outcome almost 2 years ago and now, with our established and manned office in Malta, we are able to offer a smooth transition without changing our administration and English language communication base in the UK.

For any EU medical device manufacturers concerned about this possible impact they should contact us now so we can offer a “pre-mandate” ready for such an eventuality at 30% off our standard AR fees for the first year. No invoice would then be raised until political necessity arises and a swift change over to the Maltese address, and any accompanying registrations can be made.

Contact our team if you want to know more and stop worrying about Brexit!

Certificate of Free Sale (CFS) for Medical Devices

A Certificate of Free Sale (CFS), sometimes called Free Sale Certificate (FSC) is issued by a Competent Authority, such as the MHRA in the UK or the MCCAA in Malta.

In territories outside the EU there seems to be confusion regarding who issues a Certificate of Free Sale, in this short article we will attempt to shine a light on this process.

Each member state of the EU has a Competent Authority (CA), and it is the member state where your EU Authorised Representative is located that determines the issuing CA. Advena are based in two EU locations the UK and Malta, therefore we can obtain a CFS from the MHRA or the MCCAA.

A CFS certifies that a medical device has been CE marked (CE marking) under one of the medical device directives and is available for free sale with the EU/EEA.

There are many non-EU/EEA countries who require as supporting documents for local market authorisation a CFS issued by a Competent Authority. Advena when appointed as a manufacturers EC Rep are able to provide this important documentation.

In many cases a Certificate of Free Sale must also be apostilled by the Ministry of Health/Foreign Affairs office and attested by a countries Embassy/Consulate, again Advena are able to facilitate this requirement.

For further information please contact our administration team at

Breaking News! Intertek/AMTAC

It would seem Intertek have sent out co-ordinated information regarding their future certification activities, we have now heard from multiple sources and can confirm the following important information:

Intertek has chosen to centralise its Notified Body activities to Intertek Semko AB (NB No 0413) in Kista, Sweden (SEMKO). This will lead to the closure of AMTAC, which is anticipated to take effect on 1 July 2018.

Given that many clients have experienced a less than satisfactory service from Intertek over the last 12-18 months we’re sure many of you will exercise extreme caution when considering your next steps, our advice is, whatever your decision, act now! Do not delay! And if you need our help, please do contact us.

More on this will undoubtedly follow in our next newsletter!

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