Regulatory Update Outlook - Time Extension Deadline and MDCG 2022-11 Rev1

The European Union adopted Regulation (EU) 2023/607 in view of the exceptional circumstances arising from an imminent risk of shortages of medical devices and the associated risk of a public health crisis. It became necessary to extend the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC and to extend the transition period during which those devices that are in conformity with those Directives can continue to be lawfully placed on the market. This presentation covers the background that led to the current situation, eligibility- and key- requirements of the amending regulation.

Objective

The objectives of this webinar are:

• Background that led to the current situation
• Understanding the Eligibility- and key- requirements of Regulation (EU) 2023/607
• Highlights from MDCG Q&A Document
• Application deadline of May 26th, 2024 – potential impact to your business

Agenda

• Background: Highlights of EU Commission survey of NB’s published July 2023
• Regulation (EU) 2023/607 (Entry Into Force)
• Regulation (EU) 2023/607 - Key Requirements and MDCG Q&A Document
• MDCG 2022-11 Rev.1, published November 2023:
  1. Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay

Target Audience: This webinar is aimed at regulatory professionals of legal manufacturers of medical devices who intend to continue placing products on the EU market until the end of the transition on December 31, 2028.

Language: English

Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: KN.NAM.Marketing@sgs.com

Speakers:

Ibim Tariah Ph.D
Technical Business Development Director – Medical Devices, SGS North America

Ibim Tariah Ph.D is the Technical Business Development Director – Medical Devices for SGS North America. Dr. Tariah is a globally well-known and respected expert, with a wealth of knowledge and experience including regulatory knowledge of combination devices, incorporating biologics, drugs, and drug-biologics, along with Quality Assessment of Medical Devices. His expertise lies in innovative vascular, orthopaedic & dental, and other long-term implantable devices for clients needing technical documentation assessment and reviews in compliance with the Medical Device Regulations (MDR). He has also acted as a liaison with Regulatory Authorities, including MHRA (UK), European Medicines Agency (EMA), Medical Products Agency (Sweden).

Balázs Bozsik
Technical Director - MDD/MDR, SGS

With a passion for continuous improvement, Mr. Balazs Bozsik is the Technical Director for the medical audit team of SGS North America. Following his graduation as integrated mechanical engineer from BUTE in Budapest, Hungary, he gained industrial experience in manufacturing technology and design engineering in the medical (X-ray diagnostic devices), automotive, and consumer lighting industries. Prior to joining SGS, he worked for another TIC organization for over 14 years, including his roles as global MDSAP Program Manager, certification officer, product specialist focusing on active medical devices and medical software, as well as medical auditor for all major certification schemes.

Greg Jacobson
Sales Director - Medical Devices, SGS

Greg Jacobson is the Director of Sales for the medical division at SGS North America. As a senior sales and medical device professional, he contributes to strategy, recommends resourcing requirements, and improves sales processes to drive client satisfaction. Greg has many years of experience in medical devices certification sales, where in the last 10 years he was responsible for managing high-risk device accounts. He has also held other sales roles both inside and outside of the TIC Industry.