Webinar series: clinical evaluation masterclass

Join us for our new clinical masterclass series of webinars. The timelines for ensuring your product maintains EU market access under the new, more stringent Medical Device Regulations (MDR) are challenging.

These five insightful webinars will help you focus on various aspects of the MDR, from looking at post-market clinical follow-up, to helping you with your medical device software and when a clinical evaluation is required. In addition, participants will gain a better overall understanding of the post-market requirements as listed under Articles 86 and 87 of the MDR.

Please see individual webinar information and dates below.

Date: 19 January 2022

This webinar will discuss the concept of well-established technologies under the medical device regulations and how to interpret the four criteria defined in MDCG 2020-6. This session will also cover the levels of clinical evidence required for these devices to support your clinical evaluation.

Date: 02 February 2022

This webinar will elaborate on BSI’s understanding of the unusual occasions when it is appropriate to claim that no clinical data is required for clinical evaluation. We will focus on examples of device(s) where clinical data is not required or could be impracticable. This session will also cover what can be considered a ‘claim’ under MDR considering Article 7.

Date: 16 February 2022

The medical device regulations introduce many new requirements on the regulatory aspects of claiming equivalence. This webinar will help manufacturers understand the required regulatory process in order to claim equivalence with a focus on the new requirements in relation to Class III and implantable devices. This session will also discuss the interpretation of MDCG 2020-5.

Date: 02 March 2022

With an increasing number of applications being received for medical device software, this session will look at BSI’s interpretation of MDCG 2020-1. The webinar will also help clarify when a clinical evaluation is required and the steps of a clinical evaluation process for these devices considering appropriate levels of clinical evidence for this group of devices.

Date: 16 March 2022

The medical device regulations specifically state that post-market clinical follow-up is a continuous process under the regulations. This webinar will look closely at the requirements relating to general and specific PMCF activities, how to document PMCF plans and reports using the MDCG 2020-7 and MDCG 2020-8 templates, and clarify when justifications for no PMCF are appropriate.

Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electro physiology.

Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Sheila Walsh is currently a Technical Team Manager and Clinical Team Lead in the Vascular Team at BSI.

Prior to joining BSI in 2007, Sheila was a Study Coordinator in the Clinical Neuroscience Department of St George’s Hospital. In this role she was responsible for the conduct of clinical trials, primarily focused on the use of ultrasound imaging techniques to predict stroke risk and evaluate novel anti-thrombotic regimes.

Sheila, started her career as an Engineer in Medtronic where she gained expertise in a range of implantable and non-implantable Vascular devices.

Rachel Mead holds an Honours degree in Electronics and Electrical Engineering from the University of Glasgow and is a member of the Institution of Engineering and Technology.

Rachel began her career almost twenty years ago as a research scientist in industry, where her focus was on magnetic biosensors. Since then, she has held research and development positions in medical device companies both at home and abroad. Her expertise includes technical and regulatory aspects, along with clinical investigations of medical devices.

Joining BSI as a Technical Specialist and Scheme Manager in 2018, Rachel currently holds the position of Technical Team Manager within the Active Devices Team, where she has a particular focus on clinical evaluation.

Jane joined BSI in February 2019 as a Technical Specialist, Clinical Evaluation Specialist and Scheme Manager within the General Devices team after working more than 20 years within the medical devices industry representing clinical affairs.

Prior to that Jane worked as a clinical investigator on a number of pre and post market clinical investigations and as a registered nurse within the NHS (UK). Recently Jane moved to the training team as Training Team Lead - Clinical working closely with the Clinical Compliance Group.