Medical Device Regulation (MDR) 2017/745
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.
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.
The course covers the following topics:
Introduction to Regulation (EU) 2017/745 on Medical Devices “EU MDR”
Medical device terminology
Placing a medical device on the EU Market
Structure of Regulation (EU) 2017/745 – Chapters, Articles and Annexes
Chapter II – Placing on the Market, Use of Harmonised Standards, General Obligations of Manufacturers, Authorised Representative, Distributors, Importers, PRRC, D of C.
Chapter III – Identification and traceability of devices, registration of devices and Economic Operators, EUDAMED.
Chapter IV – Notified Bodies
ISO 14971:2019 – Medical devices – Application of risk management to medical devices
Chapter V – Classification and Conformity Assessment – Section 1 Classification
Chapter VI – Clinical Evaluation and Clinical Investigations
Chapter VII – Post-Market Surveillance, Vigilance and Market Surveillance
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes
FDA 21 CFR Part 820 Quality System Regulation
Auditing Medical Device Manufacturers
Medical Device Standards
Medical Device Sterilisation, Packaging and Labelling
UK Legislation and UKCA Marking
At the end the course, you will be able to:
Understand the key differences between MDD and the new MDR
Understand how to transition from MDD to MDR
Understand how to navigate the 2017/745/EU standards
Classifying medical devices under the European MDR
Safety and performance requirements
Identify the implementation steps required to meet MDR
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
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.
| Yes, the MDR course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. |
| Places will be available for you to book unless it states ‘Full’ next to your chosen MDR course date. When this occurs, we operate a waiting list service. |
| Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. |
| You will need to first register yourself on our booking system by selecting the MDR course date that you wish to book your colleagues onto, then: - Add the number of people you wish to book onto the course - Register yourself as the booker and complete the fields accordingly - Add the details of those you wish to book for - Complete your order. |
| You will receive an automated email confirming your booking details for the MDR course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included. |
| Usually, this 1-day MDR course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000. |
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
| Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system. |
| Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. |
| Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. |
| Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email. |
| As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage. Please see our 'minimum requirements' downument for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test. |
| Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees. All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK. |
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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.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
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.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
