Learning Marketplace

Medical Device Regulation - Implications on manufacturers resources

Agreement has been reached on the new Medical Device Regulation, which will replace the current Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC). This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain. The MDR also has an expanded scope, updated classification rules, and there are more stringent requirements of Notified Bodies performing Conformity Assessments.

The impact of the changes for manufacturers must be clearly understood, and robust, timely plans should be put in place to ensure a smooth transition over the next three years. The change will impact not only Quality and Regulatory functions, but also Operations, Marketing, and Strategic Planning. Manufacturers are encouraged to understand the changes and the impact on their business, to ensure they are fully prepared to begin their transition as soon as possible, minimising the possibility of delays in getting certified under the new Regulation.

This webinar will discuss the implications of the new MDR on manufacturer's resources, and highlight some key points of note for manufacturers as they plan for the transition to the new Regulation.

Presenters

Suzanne Halliday is Head of BSI Medical Device Notified Body. She has twelve years of experience within the Notified Body. For eight years Suzanne led the Orthopeaedic and Dental team, with responsibilities for aspects of EN ISO 13485 and CE Marking for all global clients. The team was also responsible under numerous Mutual Recognition Agreements for aspects of compliance in Canada, USA, Japan, Taiwan and Australia.

In her current role, she continues to audit manufacturers' quality systems and technical documentation while leading the global Medical Devices team.

Jayanth Katta is a Certification Lead in the General Devices technology team of the Notified Body. As a Certification Lead, he manages a team of BSI Product Specialists, while also carrying out his own audits of technical documentation.

Prior to joining BSI in 2010, Jayanth was the Chief Scientist at a start-up medical device company based in Philadelphia, USA.

Jayanth has over 6 years of experience in the field of soft tissue implants and holds a PhD from the University of Leeds, UK.