00:00 Introduction

01:35 EU MDR extension
○ Implementation of the Medical Device Regulation [ Ссылка ]
○ Provisional Agenda 9th Meeting - Implementation of the Medical Device Regulation (MDR) [ Ссылка ]
○ Implementation of the Medical Device Regulation (MDR): EU MDR Transition Period extension proposal by the European Commission. [ Ссылка ]
○ Erik Vollebregt Article: [ Ссылка ]

04:29 implementing rolling plan
- Implementation Rolling Plan: Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - Latest update: November 2022 [ Ссылка ]

06:25 Borderline manual
- Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 [ Ссылка ]

08:30 Team NB - AI act for Notified Bodies
- Team-NB Position Paper - The designation of notified bodies under the upcoming Artificial Intelligence Act [ Ссылка ]

10:20 Notified Bodies appointed
- QMD Services GmbH (NB 2962), 8th Notified Body designated under IVDR (EU) 2017/746 [ Ссылка ]
- ICIM S.P.A., 36th Notified Body designated under MDR (EU) 2017/745 [ Ссылка ]

11:31 UK Approved bodies
- UK Approved bodies. [ Ссылка ]

12:35 Training to attend and Books to read
- Green Belt 24th Edition : [ Ссылка ]
- EUDAMED Simplified 28th February 2023: [ Ссылка ]
- PRRC Training 28 Feb 2023: [ Ссылка ]
- Erik Vollebregt Book - easymedicaldevice10 [ Ссылка ]

14:27 MDCG 2022-17
- MDCG position paper on ‘hybrid audits’ - December 2022 [ Ссылка ]

15:27 MDCG 2022-18
- MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate [ Ссылка ]

17:42 MDCG 2022-19 and 20
- Performance study application/notification documents under Regulation (EU) 2017/746 [ Ссылка ]
- Substantial modification of performance study under Regulation (EU) 2017/746 [ Ссылка ]

18:26 MDCG 2022-21
- Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 [ Ссылка ]

20:13 Switzerland Annex XVI products
- Frequently Asked Questions on medical devices - FAQ MD: Update of the section "Products without medical purpose" [ Ссылка ]

21:52 US Product Codes
○ Non-Invasive Body Contouring Technologies [ Ссылка ]
○ Augmented Reality and Virtual Reality in Medical Devices [ Ссылка ]

23:31 SFDA Classification
- Guidelines for classification of medical devices and supplies [ Ссылка ]

25:02 PODCAST nostalgia
- Team-PRRC panel discussion [ Ссылка ]
- Is EU MDR extended? [ Ссылка ]
- Grow your LinkedIn Profile: [ Ссылка ]

27:52 Easy Medical Device support
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#easymedicaldevice #medicaldevice #regulatorycompliance

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