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.
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
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.