Medical Device Lifetime: An Overview
The Integral Role of Lifetime in Medical Device Utilization The lifetime of a medical device is a critical period during…
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…
Reprocess of Single Use Devices: EU MDR Requirements
Article 17 of the EU MDR 2017/745 provides comprehensive guidelines regarding the requirements for the reprocessing of single-use devices. The…
Systems and Procedure Packs according to Article 22 of EU MDR
The requirements pertaining to system and procedure packs can be found in Article 22 of EU MDR 2017/745. This article…
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…
MDCG : Medical Device Coordination Group
MDCG – Medical Device Coordination Group is a new entity that has been introduced with the EU Medical Device Regulation…
Medical Device Definition according to EU MDR 2017/745
Medical Device definition has been changed with the new EU MDR 2017/745 and the impact of this change over manufacturers…
Article 120 MDR: An Overview
We have already been discussing about the requirements associated to legacy devices, mentioning as well the existence of the Article…
Free Sale Certificate according to EU MDR
The free sale certificate is an essential document to expert medical devices. These are certificates that are aiming at facilitating…
Product Life Cycle for Medical Devices
The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and…