Understand the role of an EU Authorised Representative under EU MDR 2017/745, including key responsibilities, legal liability, PRRC requirements, change of representative, and practical considerations for non-EU medical device manufacturers.
The European Commission has published Commission Delegated Regulation (EU) 2026/1359, expanding the list of eligible Class IIb implantable devices exempt from individual technical documentation assessment under the EU MDR. Learn what has changed, the practical implications for manufacturers, and key considerations for EU MDR conformity assessment.
The latest MDCG guidance provides important clarification on the transition from EC REP to EU REP under EN ISO 15223-1. Manufacturers placing medical devices and IVDs on the European market should understand the new symbol requirements, implementation timelines, labeling expectations, and the five-year coexistence period. This article reviews the regulatory update, explains what has changed, and outlines practical steps for maintaining compliance with EU MDR and IVDR requirements.
Published: 17 June 2026 The European Commission has published Commission Implementing Decision (EU) 2026/1231, introducing important updates to the list of harmonized standards supporting compliance with Regulation (EU) 2017/745 on Medical Devices (EU MDR). Harmonized standards play an important role in demonstrating conformity with the applicable requirements of the EU MDR. Manufacturers that apply the…
Read More “European Commission Updates EU MDR Harmonized Standards List” »
A practical guide to Article 117 MDR for drug-device combination products, covering GSPR compliance, Notified Body assessments, technical documentation, risk management, and European regulatory requirements.
The latest revision of MDCG 2021-24 Rev.1 introduces important clarification related to EU MDR classification requirements. Manufacturers should revisit existing classification justifications, especially for software, active devices, implantables, and borderline products undergoing technical documentation review.
