The role of the 'Person Responsible for Regulatory Compliance' in the future Medical Device Regulation and In Vitro Diagnostic Device Regulation
The new Medical Device and In Vitro Diagnostic Regulations will be published in the
coming months. One of the novelties introduced as part of this major regulatory change
in Europe is the concept of the Person Responsible for Regulatory Compliance. This was
inspired by the pharmaceutical “Qualified Person” role and has been
dramatically reviewed and diluted down since the original draft regulation proposal.
However, the basic principles remain.
The change will impact not only Legal Manufacturers, but also the Authorised
Representatives. It may appear minor compared to some of the drastic changes that the
new Regulations will bring. Nevertheless, it is crucial that medical device and IVD
manufacturers take these aspects into consideration as part of their transition plan.
This webinar will discuss the concept of the Person Responsible for Regulatory
Compliance as described in the current draft version of the Medical Device Regulation
and the IVD Regulation, provide a brief background on the Pharma Qualified Person duties
and how this concept is translated into the Medical Device and IVD world, and will cover
some of the practical aspects of the implementation of this new requirement for
Sophie Tabutin is the Regulatory Lead for BSI Notified Body. Prior to
this role, Sophie has worked in BSI as a medicinal expert, product reviewer and QMS
assessor for CE marking. In her current role, she continues to audit manufacturers'
quality systems and technical documentation while supporting the Global Medical Devices
team on regulatory matters. Sophie is a qualified pharmacist (PharmD) with a master
degree in Pharmaceutical Sciences (MSc) and has over 12 years' experience in the
pharmaceutical industry including Qualified Person role in major pharmaceutical