DescriptionReference
2.1 Scope, field of application,
definition
MEDDEV 2.1/1
MEDDEV 2.1/2 rev. 2
MEDDEV 2.1/2.1
MEDDEV 2.1/3 rev. 3
MEDDEV 2.1/4
Interpretative document of 21
August 2009
MEDDEV 2.1/5
MEDDEV 2.1/6
2.2 Essential requirementsMEDDEV 2.2/1 rev. 1
MEDDEV 2.2/3 rev. 3
MEDDEV 2.2/4
2.4 Classification of MDMEDDEV 2.4/1 rev. 9
2.5 Conformity assessment
procedure
Quality assurance.
Regulatory auditing of quality
systems od medical device
manufacturers.
(See documents:
GHTF-Part 4: Multiple Site Auditing
GHTF-Part 5: Audits of Manufacturer Control of Supplies
MEDDEV 2.5/3 rev. 2
MEDDEV 2.5/5 rev. 3
MEDDEV 2.5/6 rev. 1
MEDDEV 2.5/7 rev. 1
MEDDEV 2.5/9 rev. 1
MEDDEV 2.5/10
2.7 Clinical investigation, clinical
evaluation
MEDDEV 2.7/1 rev. 4
Appendix 1: Clinical evaluation on coronary stents
MEDDEV 2.7/2 rev. 2
MEDDEV 2.7/3 rev. 3
SAE reporting form
MEDDEV 2.7/4
2.10 Notified bodiesMEDDEV 2.10/2 rev. 1
Annex 1
Annex 2
Annex 3
Annex 4
2.12 Post-Market surveillanceMEDDEV 2.12/1 rev. 8
I. MEDDEV 2.12/1 rev. 8 – Latest
Version Forms
MEDDEV 2.12 rev. 7 MIR and FSCA are still valid
Active PDF forms
How to use FSCA and MIR forms
(* due form mancanti)
Other forms and templates
Field safety notice template
FSN customer reply
FSN distibrutor/importer reply
FSN Q&A
Trend report
Periodic summary report
II. Device Specific Vigilance
Guidance
DSVG Template
DSVG 00
DSVG 01
DSVG 02
New MIR form – as from
January 2019 (mancano 2 file)
New manufacturer incident report helptext
MEDDEV 2.12/2 rev. 2
2.13 Transitional period MEDDEV 2.13 rev. 1
As regards the transitional regime of Directive 2007/47/EC see the
interpretative document of the Commission’s services of 5 June 2009
2.14 IVDMEDDEV 2.14/1 rev. 2
MEDDEV 2.14/2 rev. 1
MEDDEV 2.14/3 rev. 1
Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10
MEDDEV 2.14/4
2.15 Other guidancesMEDDEV 2.15 rev 3