Did you know that the European Commission has adopted regulations for medical devices (MD) and in vitro diagnostics (IVD), replacing the previous EU Directives? Here’s a brief look at these new regulations and the impact they may have on your activities.
WHAT IS IT ABOUT?
The European Commission has made large changes in the regulatory framework for medical devices products.
These changes will (and already have) lead to new ways of working and new routines for both manufacturers and so-called Notified Bodies.
WHAT IS THE TIME PLAN?
-The regulations for medical device products and for in vitro diagnostic products entered into force already in May 2017. Which means that we are currently in a transition period where both systems are in force.
-For Medical Device products, the old Directives will expire in May 2020; for in vitro diagnostic products, the old Directives will expire in May 2022.
WHAT GUIDELINES ARE AVAILABLE REGARDING CLINICAL EVIDENCE?
Reinforced rules on clinical evidence were evident already in the revision of Clinical evaluation, a guide for manufacturers and notified bodies (MEDDEV 2.7/1 revision 4, June 2016). Therefore, these guidelines are helpful in preparing for the transition to the new regulation.
WHAT HAS CHANGED?
-The previous Directives are replaced by new Regulations. A regulation is directly applicable “as is”, while Directives are interpreted and incorporated into national law.
-For medical devices, there is now one regulation: The Medical Device Regulation (MDR) 2017/745. It replaces two previous directives, the Medical Device Directive (MDD) 93/42/EEC and the MDD 90/385/EEC on active implantable medical devices.
-The IVD Regulation (IVDR) replaces the directive 98/79/EC on in vitro diagnostic medical devices.
WHAT IS NEW IN THE REGULATIONS?
Several areas have been subject to revisions and changes. Some examples are listed below:
-Stricter ex-ante control for high-risk devices
-Stricter oversight of Notified Bodies
-Inclusion of certain aesthetic devices
-New risk classification system for in vitro diagnostic medical devices
-EU database on medical devices based on Unique Device Identification
-Reinforcement of the rules on clinical evidence
-Post-market surveillance requirements for manufacturers