MDR Extension According to Regulation 2023/607
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends…
Article 61 of EU MDR: An Overview
In this post, we will delve into the key requirements outlined in Article 61 of EU MDR 2017/745, which pertains…
Trend Reporting According to EU MDR and IVDR
In this comprehensive article, we will delve into the requirements for Trend Reporting as outlined in Article 88 of the…
Custom made Devices according to EU MDR 2017/745
The concept of custom-made devices is surely not new and many competent authorities have specific requirements in place to regulate…
General Safety and Performance Requirements (GSPR)
Several new requirements and topics have been introduced in medical device regulations, emphasizing the importance of specific minimum essential product…
Strategy for Regulatory Compliance according to EU MDR 2017/745
Having a Strategy for Regulatory Compliance is a new requirements clearly mentioned in the European Medical Device Regulation (EU MDR…
EU MDR QMS Requirements : An Overview
Introduction to MDR QMS Requirements A complete and comprehensive understanding of the EU MDR QMS requirements is becoming essential for…
The Role of Economic Operators within the EU MDR 2017/745
Who are Economic Operators according to EU MDR? The term Economic Operators is explained in article 2 of EU MDR…
Post-Market Surveillance for EU MDR
New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with…
Cybersecurity Requirements for Medical Devices and EU MDR 2017/745
In the last decade, the role of cybersecurity substantially increased in the medical device sector; new guidelines to define cybersecurity…