Webinar
Medical Devices

Amending Regulation (EU) 2023-607 and possible pitfalls

Providing a summary of the (EU) 2023/607 content and clarification around what are the responsibilities of manufacturers.

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Impact of legacy devices of non-compliance with (EU) 2023/607 conditions

The webinar will be useful to anyone involved in transitioning medical devices from the Directives (MDD/AIMDD) to the MDR in the EU.

EU 2023/607 and manufacturer’s responsibilities.
EU 2023/607 Non compliance NB Actions and consequences.
BSI implementation of EU 2023/607.
Process for transferring appropriate surveillance to BSI.

Amending Regulation (EU) 2023-607 and possible pitfalls

This webinar will provide attendees with the latest BSI knowledge on Amending Regulation (EU) 2023-607 and possible pitfalls.

Maddalena Pinsi, Regulatory Lead, BSI

Insights & Media

Find out about the latest quality trends with insights from our experts

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EU MDR – Post Market Clinical Follow-Up

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ISO 7101: A standard for high-quality healthcare - BSI Blog

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Maintaining Compliance IVDR post certification activities

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Annex XVI devices without an medical purpose for dermal fillers

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Ensuring trust and conformity of AI enabled Medical Devices

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Extension to IVDR transition timelines webinar

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