2 Meddev Solutions Limited (RAPS e-Book version)
Background to the MDR Chapter 2
BACKGROUND TO THE MDR
Many people reading this book will be aware of how and why we have the new EU MDR coming to Europe. If
you were not aware, here is a brief history to bring you up to speed.
Due to public outcry over scandals such as metal on metal hip implants and the infamous PIP breast implant
incident, the medical device industry regulatory system came under significant scrutiny. Also considering the
advancing technology of medical devices, and the ability of member states to interpret the directives at local
level, the existing Medical Device Directive and Active Implantable Medical Device Directive required review.
The legislative process for this review involved three parties, the European Commission, the European
Parliament and the European Council.
The European Commission had already been drafting proposals for a new Medical Device Regulation since
2008, however the PIP scandal affected that proposal by making it much stricter. In September 2012, the
European Commission announced proposals for the draft Medical Device Regulation in an attempt to address
these concerns, which caused significant debate.
In 2014 the European Parliament identified 347 amendments for the proposed MDR. The European Council
then responded in September 2015 to the proposed amendments suggested by the European Parliament. The
suggested amendments altered the original text significantly and a “Trilogue” negotiation between all three
parties ensued. The Trilogue resulted in a compromise text in June 2016. The European Medical Device
Regulation (EU) 2017/745 was formally published in May of 2017 which started a transition period of 3 years to
full implementation in May of 2020.
The MDR combines the former Medical Device Directive and Active Implantable Medical Device Directive
into one document. The regulation is directly applicable to a member state, unlike a directive which requires
implementation into the national legislation of the member state (and subsequent inconsistencies).
CHAPTER 2
Background to the MDR Chapter 2
BACKGROUND TO THE MDR
Many people reading this book will be aware of how and why we have the new EU MDR coming to Europe. If
you were not aware, here is a brief history to bring you up to speed.
Due to public outcry over scandals such as metal on metal hip implants and the infamous PIP breast implant
incident, the medical device industry regulatory system came under significant scrutiny. Also considering the
advancing technology of medical devices, and the ability of member states to interpret the directives at local
level, the existing Medical Device Directive and Active Implantable Medical Device Directive required review.
The legislative process for this review involved three parties, the European Commission, the European
Parliament and the European Council.
The European Commission had already been drafting proposals for a new Medical Device Regulation since
2008, however the PIP scandal affected that proposal by making it much stricter. In September 2012, the
European Commission announced proposals for the draft Medical Device Regulation in an attempt to address
these concerns, which caused significant debate.
In 2014 the European Parliament identified 347 amendments for the proposed MDR. The European Council
then responded in September 2015 to the proposed amendments suggested by the European Parliament. The
suggested amendments altered the original text significantly and a “Trilogue” negotiation between all three
parties ensued. The Trilogue resulted in a compromise text in June 2016. The European Medical Device
Regulation (EU) 2017/745 was formally published in May of 2017 which started a transition period of 3 years to
full implementation in May of 2020.
The MDR combines the former Medical Device Directive and Active Implantable Medical Device Directive
into one document. The regulation is directly applicable to a member state, unlike a directive which requires
implementation into the national legislation of the member state (and subsequent inconsistencies).
CHAPTER 2