10 Meddev Solutions Limited (RAPS e-Book version)
How to use this guidebook Chapter 3
TIMELINES:
The MDR has specific dates for implementation of different requirements. For example, UDI requirements
will be applied for class III and Implantable device manufacturers on the 26th May 2021, which is a year after
the general MDR applies.
MDR OVERVIEW ARTICLES:
This chapter provides an overview of the articles in the MDR. It describes each article and annex in simple
terms, i.e. what it is about, a brief summary and also the conformity evidence required. A map is also
provided to identify any links with other articles annexes.
MDR OVERVIEW ANNEXES:
This chapter provides an overview of the annexes in the MDR. It describes each article and annex in simple
terms, i.e. what it is about, a brief summary and also the conformity evidence required. A map is also
provided to identify any links with other articles annexes. Annex I includes a checklist for the safety and
performance requirements and Annex III contains a PMS checklist.
INDEXES &LOOK UPS:
References have been collated and listed to allow review of further information. This list includes acronyms,
delegating acts, other directives ®ulation and a who’s who in the MDR.
How to use this guidebook Chapter 3
TIMELINES:
The MDR has specific dates for implementation of different requirements. For example, UDI requirements
will be applied for class III and Implantable device manufacturers on the 26th May 2021, which is a year after
the general MDR applies.
MDR OVERVIEW ARTICLES:
This chapter provides an overview of the articles in the MDR. It describes each article and annex in simple
terms, i.e. what it is about, a brief summary and also the conformity evidence required. A map is also
provided to identify any links with other articles annexes.
MDR OVERVIEW ANNEXES:
This chapter provides an overview of the annexes in the MDR. It describes each article and annex in simple
terms, i.e. what it is about, a brief summary and also the conformity evidence required. A map is also
provided to identify any links with other articles annexes. Annex I includes a checklist for the safety and
performance requirements and Annex III contains a PMS checklist.
INDEXES &LOOK UPS:
References have been collated and listed to allow review of further information. This list includes acronyms,
delegating acts, other directives ®ulation and a who’s who in the MDR.