Management

An Authorized Representative (AR) is required in order to CE Mark any device where the legal manufacturer is located outside of Europe.

Therefore, as part of CE marking the legal manufacturer will need to demonstrate that an AR is contracted, and a mandate is in place to fulfil requirements related to compliance verification for a defined group of devices. The role of an EUAR is not new and has been part of the European regulatory system since its first implementation, however the new EU regulations (MDR/IVDR) bring with it more explicit requirements, responsibilities, and liability. EVNIA AR see this newly defined regulatory role as a compliance partner to the legal manufacturer. A partner that can be considered to provide expertise to ensure independent oversight of the device compliance process and perform verification that applicable regulatory processes and certification is applied in accordance with required conformity assessments. We understand this may seem like a duplication of effort; therefore, we apply a level of proportionality and also strive to drive efficiency where possible to minimise workload to manufacturers.

Having worked within the research development and regulatory functions of the med-tech industry since leaving University 20 years ago, my passion is advising and supporting device companies bring their products to market in a compliant way. Our industry shared goal whether you are an investor, designer, manufacturer, test house, consultant, Notified Body, Competent Authority through to all other economic operators is to bring safe and effective devices to market that offer clinical benefits that far outweigh the risks and harms. As a regulatory professional, this is the principal factor over every project, piece of advice or strategic guidance we provide. We work in an industry where patient safety should always be a priority in everything we do. As an EUAR, we offer the oversight necessary to fulfil regulatory requirements but also remain focussed on delivering safe devices to market by our experience and expertise in this field.

I am fortunate to have worked with a number of large, multinational companies leading EU regulatory activities and also been part of smaller start-up companies during my career within regulatory. I have therefore experienced working with a range of sized and structured companies, many technologies, all risk classes and in a variety of diagnostic and therapeutic spaces. This diverse experience provides me with a great understanding of the industry and the experience needed to lead our European Authorised Representative services.

EVNIA AR is a trusted partner that can become part of your compliance team and provide more than the obligated regulatory actions required by the regulation, but an extension to you regulatory and clinical teams, when needed.