WEBINAR: European Authorised Representatives and Economic Operators

The UK has left the European Union as of the 1st of January, this means that UK based manufacturers face a series of new challenges in regards to establishing continued access to Europe. Under both the European MDR and IVDR regulations specific roles are defined for actors supporting the supply chain. This includes Importer, Distributors, and the appointment of EU Authorized Representatives.

In this webinar, we will be exploring the requirements for these parties, the requirements which need to be in place transition, and the strategic considerations organisations should be planning for if they wish to maintain access to the European market going forwards.

The session is intended for business, Quality, and Regulatory leaders and will feature 40 minutes of presentation followed by a 20 minute Q&A session.

Duration: 1 hour

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Speaker Profile:

Richard Young, Managing Director, AcclaimBiomedical Consulting Ltd

Richard has an extensive background in regulatory affairs in addition to GMP (quality assurance), GLP (laboratory testing), and GCP (clinical). Spanning over two decades, these core skill areas have been developed with experience in products ranging from class 3 devices such as Orthopaedic implants (IIb) neurological robots, through electromedical devices such as infusion systems and cardiovascular products.

Richard brings a blend of pragmatism and experience to these disciplines that facilitate insightful problem-solving approaches as well as solid solutions.

Richard’s skills and experience includes such areas as the development and implementation of effective quality management systems, auditing to ISO and FDA QSIT standards, and operating at national and international level through industry associations including Eucomed, ABHI, and ABHI Technical Policy Group.