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Management Forum

A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK In-house Training

Where are we now and the future developments in the EU 27 and the UK

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

★★★★★ "Was very useful. I feel I accomplished further knowledge about the implementation of MDR and IVDR an... more (18)"

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Format: Bespoke training
CPD: 6 hours for your records (depending on your requirements)
Certificate of completion

Course overview

Stay informed on the significant changes since the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR).

The landscape of medical device and in-vitro diagnostic regulations in the EU and UK has undergone significant transformation in recent years. With the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR),, the regulatory framework has become more rigorous and complex. Staying abreast of these changes is crucial for professionals involved in regulatory affairs, quality assurance, and related fields to ensure compliance and maintain market access.

This course is essential for those seeking to stay fully updated on the latest regulatory developments.

Key topics to be addressed:

Comprehensive insights into the rephrased implementations of MDR and IVDR
Understand the new guidelines
Learn about the role and output of the Medical Device Coordination Group (MDCG)
Recent medical device regulatory developments in the UK, providing a comparative perspective on the evolving regulatory landscape
Explore potential future developments and the evolving role of the European Medicines Agency (EMA) in the context of medical device regulations

This course offers a unique opportunity to hear from regulatory experts, discuss the implications of current and forthcoming regulations on working practices, and understand the potential impact on future regulatory strategies.

Please note: This programme has been designed to reflect the most current understanding of the regulatory landscape for medical devices and IVDs. The content will be delivered using the latest available information at the time of presentation, adapting to any regulatory developments that emerge beforehand. Attendees can expect a clear overview of current requirements, insight into forthcoming regulatory changes, and informed discussion of future developments, including evolving controls on software, AI-supported devices, and healthcare applications.

This course is part of our range of Medical Devices training courses

Benefits of attending

Stay updated on MDR and IVDR implementations, new guidelines, and recent UK regulatory developments
Explore the changes in the UK regulation as its system becomes independent and moves away from the EU rules
Navigate the increasingly complex world of device and diagnostic regulations
Gain insights into future changes to the regulations and how "digital medicine" may be regulated in the future
Learn from leading regulatory experts and gain practical advice

Who should attend

This training course has been designed for all those working or interested in the medical device and diagnostic market in the EU and the UK, including medical device and in-vitro diagnostic professionals from the following areas:

Regulatory affairs
Clinical studies
Vigilance
Post-market surveillance
Quality systems
Technical support and business development

Popular with...

This course has proven particularly popular among our customers in these roles:

RS
Regulatory Affairs Manager
Regulatory Affairs Specialist
Senior Advisor in the Department for Medical Devices

Reviews of IPI's A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK training course

Was very useful. I feel I accomplished further knowledge about the implementation of MDR and IVDR and also what is on the horizon in terms of the UK regulations from the course. The content of update on IVDR was great as it was directly related to my work. I also enjoyed learning more about the history of the regulations/legislative process and gained some useful background knowledge on combination products.

Apr 30 2025

Liz Gillman United Kingdom
Clinical Compliance Project Lead, LifeScan Scotland

Oct 22 2024

Very good course.

Richard Jones United Kingdom
Senior Medical Device Auditor, Eurofins E&E CML Limited

Sep 24 2019

Very well run, met my objectives, and speakers were interesting, approachable and very knowledgeable.

Lucie Green United Kingdom
QA Manager, Vyaire Medical Products

Mar 6 2019

Excellent training performed by very knowledgeable speakers.

Marie-Pierre Hontas France
Senior Director Scientific & Clinical Affairs, Vexim SA – Stryker IVS

Sep 24 2019

Management Forum have become my go-to provider of life science training. They always find excellent speakers who present their subject matter in a very knowledgeable, complete and thoroughly enjoyable way. I have always found Management Forum courses to be excellent value for money and the New Medical Device Regulation course was no exception.

Stephen Matthews United Kingdom
Validation Consultant, Smart Process Solutions Ltd.

Sep 24 2019

A relaxed, open forum where you felt comfortable to ask any questions you needed through the presentations and the day. The speakers were all very clear, concise, factual and interactive.

Holly Widnall United Kingdom
Project Manager, Bedfont Scientific Ltd

Sep 24 2019

The speakers were very professional and knowledgeable. They delivered the content in an easy format and allowed plenty of time for questions and interaction from the attendees. I particularly liked the section regarding the context of the regulation and background to its development which will help me when explaining this to my clients.

Stephen Rowe United Kingdom
Managing Director, SGR Consulting Services Ltd

Sep 25 2018

[The speakers were] all very knowledgeable. The whole course was very reassuring with the 'big monster' of the MDR being broken down so that it appears manageable and less scary. It was full of helpful advice both general and specific to my products.

Samantha Workman United Kingdom
ISO Manager, Torbay and South Devon NHS Foundation Trust

Sep 25 2018

Good, complete coverage of the new regulations. Good anticipating on discussed items.

Marcel Steenhof Netherlands
Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV

Feb 26 2018

Excellent speakers

Iva Ujevic Croatia
Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Feb 26 2018

Excellent speakers

Iva Ujevic Croatia
Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Feb 26 2018

Very good.

Marie-Cécile Lerat United Kingdom
RA Manager MPS Europe, Becton Dickinson

Sep 26 2017

This was an excellent introduction to the Medical Device Regulation, focussing on the key changes and considerations to prepare for compliance with the new requirements. The experienced speakers provided much needed guidance and expertise.

Kate Cole United Kingdom
Regulatory Affairs Manager, Xiros Ltd

Sep 26 2017

Excellent, both content and speaker line up

Zinovia Chatzidimitriadou United Kingdom
Associate, Bristows LLP

Sep 26 2017

The speakers were very knowledgeable and lovely people and on the forefront of the devices industry. The presentations were very clear and interactive. The course was excellent and I would highly recommend to anyone wanted to learn about the new MDR.

Daniel Terzian United Kingdom
Project Assistant, NDA Regulatory Science Ltd

Feb 8 2017

Great content

Andrew Whitton United Kingdom
Medtrade Products Ltd

Feb 8 2017

The speakers all did a great job, they were committed and inspiring.

Dorte Reland Denmark
Director, PV Operations, LEO Pharma A/S