Extension to the MDR transition timelines – impact on manufacturers and Notified Bodies

What is the webinar about?

The EU Commission proposal to extend the MDR transition timelines was approved by the European Parliament in February 2023 and is anticipated to come into effect mid-March once it receives final approval from the EU Council and is published in the Official Journal of the European Union.

The proposal provides additional time for devices transitioning to the MDR by extending the transition timelines specified in Article 120 of the MDR to either the end of 2027 or 2028 based on the classification of the devices. At the same time, for devices transitioning to MDR, their Directive Certificates will be recognised as being valid even beyond their expiry dates until the end of 2027 or 2028 to enable manufacturers to place such devices on the market based on their Directive Certificates. However, the additional time comes with conditions attached that the manufacturer must fulfil.  

Join this webinar to learn more about this new amending Regulation and how you can benefit from it.

Who should attend?

Anyone involved in transitioning medical devices from the Directives (MDD/AIMDD) to the MDR in the EU.

What will participants gain?

A clear understanding of the new amending Regulation and its impact, especially in relation to:

• The new transition timelines, which devices benefit from them and under what conditions
• Conditions under which devices covered by expired MDD/AIMDD certificates can benefit from the longer transition timelines
• Abolishment of the sell-off provisions in the MDR and its impact
• Transfer of appropriate surveillance from your Directive Notified Body to the MDR Notified Body (in cases where these are different)
• Notified Body implementation of the new amending Regulation and potential timelines

Jay is a Regulatory Director within BSI and the Head of the Notified Body for Medical Devices. He is responsible for the regulatory oversight of Notified Body activities for medical devices and wider BSI strategy, policies, procedures, and documentation to meet the various legislative and designation requirements. He has held other BSI roles such as Head of UK Approved Body, Head of Training, Technical Team Manager, Technical Specialist & Scheme Manager prior to the current position.

Prior to joining BSI, Jay was the Chief Scientist at a start-up medical device company developing innovative soft tissue repair and replacement therapies. He holds a PhD in Biomedical Engineering from the University of Leeds.

Suzie is VP Regulatory, she has eighteen years of experience within BSI. In her current role, she develops strategies, policies and processes for the Medical Devices team to ensure compliance with global regulatory requirements.

Prior to Suzie’s work at BSI, she completed a Bachelor Degree and Masters in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford).

Suzie has worked in orthopaedic hospitals in Australia, Canada, Japan, UK and the USA, testing joint replacement implants, spinal and fracture fixation systems. She has also led clinical investigations on orthopaedic implants.