Medical Device Regulation (MDR) 2017/745

Preparing for MDR Compliance with Comprehensive Training on EU Medical Device Regulation ISO 13485 and Gap Analysis

Compliance with the Medical Device Regulation (EU) 2017/745 (MDR) presents many new challenges to medical device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges in order to smoothly bring your device to market under Medical Device Regulation (EU) 2017/745 (MDR). 

 

Learn how to interpret and navigate the regulations, determine device classification and understand device conformity assessment routes. The course will address the enhanced requirements under the Regulation, General Safety and Performance Requirements (GSPRs), and clinical evidence, post market surveillance, including periodic safety update reports and vigilance. 

 

As well as looking into the role of competent authorities and notified bodies, the course covers the requirements to keep your device compliant under the existing Medical Device Directive (whilst your CE Certificate remains valid). 

 

The course features interactive workshops, including an in-depth look at ISO 13485, providing  the opportunity for one-to-one discussion with the course tutor during the break-out sessions. To cater the training further, all delegates will complete a gap analysis exercise, allowing you to review your current products and assess compliance against the new legislation. 

 

Interested in Medical Device Regulatory training for your team? Contact us today. 

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Duration
1 day
CPD Hours
7 hrs
Locations
  • Online

Who Should Attend

The course is intended for individuals that work for a Medical Device manufacturer or CMO who hold responsibilities that require them to understand Medical Device Regulation (EU) 2017/745 and the differences/issues from the current MDD. In particular, Quality Management, Quality Assurance, regulatory affairs, design and development, clinical affairs specialists, authorised representatives, economic operators (including importers and distributors) may find this course beneficial. 

Key Topics

The course covers the following topics: 

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    Introduction to Regulation (EU) 2017/745 on Medical Devices “EU MDR” 

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    Medical device terminology 

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    Placing a medical device on the EU Market 

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    Structure of Regulation (EU) 2017/745 – Chapters, Articles and Annexes 

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    Chapter II – Placing on the Market, Use of Harmonised Standards, General Obligations of Manufacturers, Authorised Representative, Distributors, Importers, PRRC, D of C. 

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    Chapter III – Identification and traceability of devices, registration of devices and Economic Operators, EUDAMED. 

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    Chapter IV – Notified Bodies 

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    ISO 14971:2019 – Medical devices – Application of risk management to medical devices 

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    Chapter V – Classification and Conformity Assessment – Section 1 Classification 

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    Chapter VI – Clinical Evaluation and Clinical Investigations 

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    Chapter VII – Post-Market Surveillance, Vigilance and Market Surveillance 

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    ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes 

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    FDA 21 CFR Part 820 Quality System Regulation 

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    Auditing Medical Device Manufacturers 

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    Medical Device Standards 

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    Medical Device Sterilisation, Packaging and Labelling 

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    UK Legislation and UKCA Marking 

Learning Outcomes

At the end the course, you will be able to: 

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    Understand the key differences between MDD and the new MDR 

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    Understand how to transition from MDD to MDR 

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    Understand how to navigate the 2017/745/EU standards 

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    Classifying medical devices under the European MDR 

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    Safety and performance requirements 

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    Identify the implementation steps required to meet MDR 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Lisa Banwell

Lisa Banwelll

Lisa is a skilled Quality and Regulatory Consultant with a strong background in medical device manufacturing, pharmaceutical analysis and fine chemical manufacturing. Specialising in auditing, inspection management, regulatory strategy and authority communication across diverse products, Lisa’s experience covers infusion devices, contact lenses, sterile single-use devices and neurophysiological and vascular diagnostic equipment.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Provides essential background knowledge

The Medical Device regulation course provided essential background knowledge and had very interesting exercises.
Rene Friedrichs
RSSL

Useful

useful for background information
Anonymous
Britannia Pharmaceuticals Ltd

Book Your Place

Medical Device Regulation (MDR) 2017/745
07 May 2025
-
Online
29 Oct 2025
-
Online
£590 excl VAT
Istock 687663018 (1)

Bespoke Training

We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Why choose RSSL?

As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community