Harmonised Standards and EU MDR 2017/745
Harmonised standards (HS) play a pivotal role in the European Union’s regulatory framework for medical devices, particularly under Regulation (EU)…
Substantial Changes for Design and Quality System: an Overview
The definition of substantial changes has always been very critical for medical device manufacturers. We have already been talking about…
EU Declaration of Conformity
The Declaration of Conformity is one of the key document asked to be prepared by medical device manufacturer in order…
Quality Agreement: An Overview
Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS…
UDI Requirements for EU MDR and IVDR
The introduction of the UDI system for the medical device business can be considered a revolution and now the MDR…
Legacy Devices and EU MDR Requirements
In this specific moment where the new EU MDR 2017/745 is officially entered into force, the management of the so-called…
Implantable Medical Devices and related EU MDR Requirements
Implantable medical devices are usually highly risky devices for which a potential failure may cause serious consequences to the patient.…
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…