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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.

Advena Receives ISO 13485:2016 Certification

 

As a medical device regulatory and quality management (QMS) consultancy we place considerable value in holding our own ISO13485:2016 certified QMS.

We are therefore pleased to announce receipt of our new ISO13485:2016 certificate covering the following scope ‘European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers’.

Having this much sought-after certification underpins our ability to help, assist and guide manufacturers through this process, therefore if you are also looking to transition to the 2016 version of this standard or are ready to implement your own quality management system please do get in touch with us, we have a team of experts ready to help.

Email: info@advenamedical.com

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