RAPS Workshop: EU MEDICAL DEVICE REGULATION 2017/745 (March 2026)

The EU Medical Device Regulation (MDR) has certainly caused significant impact to the medical device industry. Regulatory and quality professionals are still learning some of the nuances, and with the extended time frame for compliance, some companies are still navigating their way through the requirements.

If you are unsure of what is required, then join us as we explore the nuances of the regulation and make sense of what you need to do in a practical way, with easy-to-understand examples.

Receive useful advice on updating your quality system, overseeing economic operators, addressing labeling, and handling technical documentation.

Registration Fees & Deadlines

Learning Objectives

Upon completion of this workshop, participants will be able to:

• Appreciate the history, purpose and structure of the MDR
• Identify devices covered by the MDR and how to classify them
• Know what manufacturers, economic operators and the PRRC are required to do
• Understand the GSPRs and features of a risk management system based on ISO 14971
• Explain the contents of the technical documentation
• Apply PMS and Vigilance requirements for different device classes
• Outline the basic clinical data requirements
• Identify the UDI requirements and the relationship with Eudamed

Who Should Attend?

There are no formal pre-requisites required for this course. This course applies to anybody that requires an understanding of the EU MDR.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

Speakers

Rod Beuzeval, RAC
Principle Trainer, Leap Compliance

Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices. He has worked in the medical device and pharmaceutical industry for over 22 years, including time spent in some of the largest medical device and pharmaceutical manufacturers. Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP. Rod’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients update their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP and QMS systems.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions