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 and transition smoothly to the MDR.

This course focuses on what is required to bring your Medical Device to market under Medical Device Regulation (EU) 2017/745 (MDR).

Learn how to interpret and navigate the new 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), Clinical Evidence, Post Market Surveillance including Periodic Safety Update Report and Vigilance etc. The course will also look at the role of Competent Authorities and Notified Bodies.

Also covered during the course are the requirements to keep your device compliant under the existing Medical Device Directive whilst your CE Certificate remains valid.

The course will feature interactive workshops, include an in-depth look at ISO 13485 and provide the opportunity for one to one discussion with the Course Tutor at break-out sessions. Delegates complete a gap analysis exercise, allowing you to review your current products and assess compliance against the new legislation.

Classroom courses - please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.

The course is intended for individuals that work for a Medical Device manufacturer or CMO who's responsibilities require them to have an understanding of 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, Authorized Representatives, Economic Operators, including importers and distributors.

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