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10 September 2026: AMMI Global Expert Sharing on Navigating European Market Access with CE Marking & Clinical Evaluation

AMMI organised a full-day Global Expert Sharing seminar, “Navigating European Market Access with CE Marking & Clinical Evaluation,” led by Mr Richard Holborow (BSI) at Olive Tree Hotel, Penang. Over 50 AMMI members attended the event.

The seminar covered EU regulatory updates for CE marking, an overview of Clinical Evaluation and ISO 14155:2020, Clinical Evaluation under the EU MDR, preparation and content of the Clinical Evaluation Report (CER), and MDR Notified Body expectations for clinical evidence, with practical guidance on aligning clinical strategies to current regulatory requirements.

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1 Nov 2017: AMMI Global Expert Sharing Session on EUMDR

Over 60 members and guests attended the AMMI Global Expert Sharing Session on EU Medical Device Regulations at E&O Hotel Penang on 1 November 2017. The objective of this event is to provide insight and facilitate discussion among AMMI Members and key stakeholders on the impact of the new Medical Device Regulations in Europe for the Medical Device Industry. The event started off with the Key Note Presentation on “Challenges and Expectations of the New Medical Device Regulations in Europe for the Medical Device Industry”  by Mr Juergen Heil, Senior Vice President Quality & Environment Management, B. Braun Melsungen AG, Germany, This was followed by a Panel Discussion led by Mr Frank Ried, Director of Ried Q&C Consultancy. The distinguished panel members also included Mr Juergen Heil, Peter Porzler, Vice President, Medical & Health Service (MHS), Global Non-Active Medical Devices, TUV SUD and  Mr Tony Low, Director of Quality Assurance & Regulatory Compliance, Commissioning Agents International .
Watch the video highlights here…
From left to right : Mr  H.T. Eow (AMMI Secretary-General/ Managing Director of Abbott, Mr Juergen Heil, Mr Frank Ried, Mr Peter Porzler, Mr Tony Low and Mr CS Ching (AMMI Executive Director).
Members and guests signing in….
Refreshments and networking before the start of the session…
Welcome Remarks by Mr HT Eow (AMMI Secretary-General / Managing Director of Abbott)
Keynote Presentation on“Challenges and Expectations of the New Medical Device Regulations in Europe for the Medical Device Industry”  by Mr Juergen Heil.
Panel Discussion led by Mr Frank Ried together with Mr Juergen Heil, Mr Peter Porzler and Mr Tony Low
Mr HT Eow presenting tokens of appreciation to Mr Juergen Heil, Mr Peter Porzler, Mr Frank Ried and Mr Tony Low.
Mr CS Ching updated guests on upcoming AMMI events and training programme before wrapping up the session. It was indeed a very fruitful evening, with a very comprehensive sharing session from the global experts.