Course Information

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

Session 1

19 October 2023

120 mins | 10:00 AM UK

Module 1: Introduction to medical devices

Using examples, we will illustrate a range of devices, accessories to devices and borderline products.

• What qualifies as a medical device?
• Medical device vs In Vitro Diagnostic Medical Device
• Examples illustrating what devices are classified, accessories to devices and borderline products
• Understanding ‘economic operators’ and their roles
• Reimbursement and payers – Who are the payers for devices?

 

Module 2: How are medical devices regulated in Europe and the UK?

To ensure patient safety, every medical device has to comply with the current regulations. But what regulations apply to different types of medical devices and what do I have to do to comply?

You will get a high-level overview of applicable regulations in the EU and UK, a summary of the classification process and how that leads to different levels of scrutiny by third parties such as Notified Bodies and Competent Authorities.

• High-level overview of applicable regulations
• Understanding the Medical Devices Regulation (MDR) and its relationship with standards
• The classification process in relation to the need for different levels of scrutiny
• Introduction to Notified Bodies and Competent Authorities.
• Penalties for non-compliance
• Medical Device regulations in the US and other global markets

 

Session 2

19 October 2023

120 mins | 1:00 PM UK

Module 3: Getting a device to market: Design, development and regulations

You will receive a high-level overview of what’s involved to get a new medical device to market and the potential risks and pitfalls. We will discuss the timescales and costs associated with achieving compliance and your obligations as a manufacturer, importer or distributor / retailer.

• High level overview of what is involved to get a new medical device to market
• Understanding the timescales and costs involved
• Planning for medical device testing and the gathering of ‘clinical evidence’
• Planning for quality and risk management through the development phase
• Understanding that regulatory compliance alone is not sufficient for commercial success. High level overview of how health technology assessment and reimbursement work

 

 

Module 4: Keeping a device on the market: ongoing compliance

Getting your product on the market is only the start. How do you ensure that it does what it’s supposed to do and is safe? What do I do if there is a problem?

You will receive a high-level overview of what’s involved in keeping your medical device on the market. We will discuss your ongoing obligations as a manufacturer, distributor or retailer to maintain compliance with the regulations and keep your product safe for its intended use.

• High level overview of your responsibilities
• Understanding the rules for reporting to authorities
• Quality control and risk management
• Keeping track of product records and user feedback
• Understanding patient safety
• What to do when it all goes wrong

 

What to do next

• Who needs specific training and why?
• What training is available

 

 

Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems.  Starting out as company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager.

 

Anne has run her own consultancy business since 2000 providing medical device regulatory support to companies ranging from research institutes and start-up companies to SMEs and multi-national market leaders.  Anne was one of the founders and visiting lecturers to the MSc in Medical Technology Regulatory Affairs run by TOPRA and Cranfield University where she was also external examiner from 2009 to 2012.

 

Anne has extensive MDR expertise, supporting her clients transition from the MDD as new guidelines and ISO standards are published. As a result, she can draw on multiple case study examples and experience when delivering MDR training courses. Anne has led both in-house and public courses on medical device EU regulatory affairs for several years.

 

Anne is also Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.