This short webinar will explain what the latest timescales are, and what changes have been made to the MDR since it was first published. Peter Rose, Director of PRQR Ltd will go through the main points of change and provide practical advice on what to do in preparation for going live next year. The extension should not be seen as time for a break but more as time to get things right for a smooth and trouble free transition with no interruption to supply of your products to the EU market. The webinar will also briefly discuss Brexit and what we might expect from the new Medicines and Medical Devices Bill.
– New deadline date
– The Changes – 2 corrigenda, a formal M1 revision including significant changes for Class I Devices
– Notified Body Capacity – Act Now!
– The B word (Brexit)
– The new Medicines and Medical Devices Bill including the Cumberlege Review
– Resources
DURATION: 1 hour
This free to attend event is held as part of the INSTILS programme – a project part-funded by the European Regional Development Fund, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses, the value of which is £127, but is delivered completely free of charge to participants.
Speaker Profile:
Peter Rose, Director, PRQR Ltd
Peter is the founder and principal consultant of PRQR Ltd. With over 26 years of experience working in the field of Medical Devices and In Vitro Diagnostics, Peter has expertise covering Quality Assurance, Regulatory Affairs, Sterilisation, Cleanrooms and Contamination Control.
Peter is a qualified Microbiologist, a Chartered biologist, Member of the Royal Society of Biology, Practitioner Member of the Chartered Quality Institute and a Member of TOPRA. Peter has an abundance of experience and expertise in Quality, Regulatory and microbiological matters for Medical Devices and IVDs across the UK and Europe.
Peter possesses a range of technical and business skills that enable him to provide unique insight to new and emerging businesses. He takes a hands-on approach to challenges and is adept at creative problem-solving. As a highly driven and entrepreneurial business leader, Peter has extensive senior leadership and board-level experience. As a well-regarded voice within the industry, Peters holds the position of Director within Medilink East Midlands, sits on a variety of industry committees and working groups and has been invited to address the European Parliament and Government ministers.
Peter’s extensive experience includes the new Medical Device Regulation, the new IVD Regulation the three established Medical Device Directives. He also has expertise in quality management systems covering ISO 9001, ISO 13485 and 21 CFR 820 (QSR).
