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.
