EU Medical Device Regulation 2017/745
- Starts 26 SeptStarts 26 Sept
- 995 British pounds£995
- Online Virtual Classroom
The MDR (EU 2017/745) has replaced the MDD (93/42/EEC) as the legislation detailing the requirements that manufacturers must comply with in order to place medical devices on the market within the EU. Our industry leading experts have created a 2-day course to help medical device manufacturers understand the additional requirements of the regulation, so you know what you need to do for your business and products to meet the new MDR. Agenda Overview Module One - History, purpose and structure of the MDR - Key terminology and definitions - EU-MDR timelines for transition - Brexit - Devices in and out of scope - MDR main changes - Non-Medical devices Module Two - Placing a device on the market - Manufacturer’s articles & obligations - Economic Operator & PRRC Responsibilities - Declaration of conformity - Procedure packs, spares and components - CE Marking Module Three - Overview and structure of the classification Annex VIII - Class Types & Classification Rules - Notified Body certificates - Routes to conformity Module Four - The General Safety and Performance Requirements - Chapter I General Requirements - Risk Management - Chapter II Design & manufacture requirements - Chapter III Device Information Module Five - Clinical Evaluation requirements - Post Market Surveillance - Summary of Safety and Clinical Performance - Vigilance - Clinical Evaluation and PMCF Module Six - Annex II and Annex III Technical documentation - Unique Device Identification (Annex VI) - UDI Timelines - Overview of Eudamed - Guidance What you will receive: - 2-days of interactive training - Certificate of completion - Q&A session - Indexed copy of the MDR - Copies of the slides and handouts - 15% off the MDR Guidebook What you need: - Internet access with Google Chrome - Access to a microphone (Webcam not required) This training course is delivered over 4 days in half day sessions to reduce time out of the business for busy professionals. Discounts are available for 3+ attendees. Please email us at email@example.com for your unique discount code to use at the checkout.
Places are non-refundable. Substitutions may be made at any time at no additional charge.
Meddev Solutions, 30 Monaghan Street, Newry Co. Down, BT35 6AA, N.Ireland GBR