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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.

Brexit and Access to the EU Market for Medical Devices

There is considerable uncertainty regarding the commercial impact of Brexit and how this will affect medical device manufacturers who CE mark devices and use a UK based EU Authorised Representative (EC REP) and label their devices with a UK address.

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.

The key date at the moment is the 29th March 2019, after this date UK based EC REP’s may no-longer be permitted to legally act as an Authorised Representative to a non-EU manufacturer (click here).

Notified Bodies have already been suggesting that manufacturers look for an alternative EC REP who is based in one of the other 27 EU member states.

This negative news is further emphasised by the fact that UK Notified Bodies have now assured that they have their own EU operational addresses outside the UK so they may continue their certification business.

For Advena Ltd, and our non-EU clients, the good news is Brexit carries very little risk as we have two EU locations, one in the UK and the other in Malta.

Therefore in the event of a ‘hard’ Brexit Advena’s clients will be transferred to our Maltese office and self-declared registrations will similarly be transferred.

We strongly recommend any non-EU manufacturer of medical devices who currently use a UK based EU Authorised Representative (EC REP) contact Advena to discuss changing from your current service provider to Advena in Malta and benefit from our 20 year’s experience as a provider of medical device regulatory services.

As a valued Advena client EU market access is guaranteed.

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

EU Authorised Representative (EC REP) & Unannounced Audits

Notified Bodies seem to be placing greater scrutiny on medical device manufacturers who have appointed an EU Authorised Representative (EC REP) with particular reference to unannounced audits.

As many of you may already know, Notified Bodies now consider the EC REP a critical subcontractor and are therefore subject to an unannounced audit by the manufacturer’s Notified Body, in accordance with the Commission Recommendation 2013/473/EU.

One leading UK Notified Body has issued a major non-conformity to a US based manufacturer due to their Dutch based EC REP not allowing for an unannounced audit as required under 2013/476/EU.

This meant that the Notified Body would not issue a CE certificate until this major non-conformity was closed out.

Advena have been aware of 2013/476/EU since it was published and were requested to help and take over the responsibilities as EC REP for this manufacturer. Of course, we were very happy to help.

It should therefore come as a great comfort to our clients and prospective clients alike that Advena are a professional organisation that takes its responsibilities seriously and with 20+ years’ regulatory experience, we have a wealth of knowledge which clients can tap into.

From this example of how Notified Bodies are assessing a manufacturer’s EC REP it should help make the decision process in appointing an EC REP much simpler.

By choosing Advena as your EC REP, you not only gain access to our regulatory experts, extensive experience and knowledgeable advice, you avoid this major non-conformity.

ISO 13485: 2016 MDSAP – Gap Analysis

ISO13485:2016 is the most recent version of quality management system (QMS), specifically for medical device manufacturers and is now considered the ‘gold’ standard.

Manufacturers have until March 2019 in order to update their current ISO13485 QMS to this latest version and become certified.

In addition if it’s your intension is to access USA, Brazilian, Japanese, Australian and/or Canadian markets you will be required to comply with the requirements of the Medical Device Single Audit Program (MDSAP).

At Advena we have experts who specialise in guiding manufacturers to compliance whether it’s ISO13485:2016 or with the additional requirements of MDSAP and the first logical step is to perform a gap analysis.

The Advena gap analysis will evaluate your QMS and assess your level of compliance, identifying any gaps, deficiencies or nonconformities when comparing to your current QMS to the standard you wish to achieve.

After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Advena can upgrade your QMS for an agreed fee.

This service is particularly helpful for SME’s and start-up organisations whose depth of resources may not allow a gap analysis to be conducted internally.

For more information on how Advena can assist with assessing your QMS to either ISO13485:2016 or to include the requirements of MDSAP certification or even to implement a new QMS please contact us at info@advenamedical.com for a detailed quotation.

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