EU Regulations and Directives

Major Regulations

Document

Language

Number

Published

* Europe Medical Devices Regulation

en  fr

MDR

05/2017

** Europe IVD Regulation

en  fr

IVDR

05/2017

European Active Implantable Medical Devices Directive (AIMDD)

en  fr

90/385/EEC

06/1990

European Cosmetic Products Directive

en  fr

1223/2009

11/2009

European In-Vitro Diagnostic Devices Directive (IVDD)

en  fr

98/79/EC

12/2011

European Medical Devices Directive (MDD)

en  fr

93/42/EEC

06/1993

European Personal Protective Equipment Directive

en   fr

89/686/EEC

12/1989

Regulation amending the European MDD 93/42/EEC and others

en  fr

2007/47/EC

9/2007

 

 

General Guidance Documents

Document

Language

Number

Published

EU - GHTF Guidelines for Auditing Mfg Control of Supplier - Part 5

en 

GHTF/SG4/N84:2010

08/2010

EU - GHTF Guidelines for Multi-Site Auditing of QMS Part 4

en 

GHTF/SG4/N83:2010

08/2010

Interpretation of implementation of Directive 2007/47/EC

en  fr

2007/47/EC

06/2009

MEDDEV 2.1/1 - Defines Medical Devices, Accessories and Manufacturer

en 

2.1/1

04/1994

MEDDEV 2.12-2 rev 2 - Post market clinical follow up for medical devices

en 

2.12-2 rev 2

01/2012

MEDDEV 2.2/1 rev 1 - Addresses EMC requirements

en 

2.2/1 rev 1

02/1998

MEDDEV 2.2/3 rev 3 - Discusses the Use By date

en 

2.2/3 rev 3

06/1998

MEDDEV 2.2/4 - Conformity Assessment of IVF and ART Products

en 

2.2/4

01/2012

MEDDEV 2.4/1 rev 9 - Classification of medical devices

en 

2.4/1 rev 9

06/2010

MEDDEV 2.5/3 rev 2 - When a quality-related inspection of a subcontractor is needed

en 

2.5/3 rev 2

06/1998

MEDDEV 2.1/2 rev 2 - Application of the Active Implantable Device Directive

en 

2.1/2 rev 2

04/1994

MEDDEV 2.1/3 rev 3 - Demarcation between MDD and Medicinal Products Directive

en 

2.1/3 rev 3

12/2009

MEDDEV 2.1/4 - Discusses demarcation between the EMC and PPE Directives

en 

2.1/4

03/1994

MEDDEV 2.1/5 - Addresses medical devices with a measuring function

en 

2.1/5

06/1998

MEDDEV 2.10/2 rev 1 - Designation and monitoring of Notified Bodies

en 

2.10/2 rev 1

04/2001

MEDDEV 2.12-1 rev 8 - Guidelines on a medical devices vigilance system

en 

2.12-1 rev 8

01/2013

MEDDEV 2.14/1 rev 2 - Borderline issues between the IVD and Medical Device Directives

en 

2.14/1 rev 2

01/2012

MEDDEV 2.14/2 rev 1 - Dealing with IVD products for research use only

en 

2.14/2 rev 1

02/2004

MEDDEV 2.14/3 rev 1 - Requirements for e-labeling of IVDs

en 

2.14/3 rev 1

01/2007

MEDDEV 2.15 rev 3 - Committees and organizations related to medical devices

en 

2.15 rev 3

12/2008

MEDDEV 2.5/10 - Guideline For Authorised Representatives

en 

2.5/10

01/2012

MEDDEV 2.5/5 rev 3 - Clarifies translation procedures

en 

2.5/5 rev 3

02/1998

MEDDEV 2.5/6 rev 1 - Defines homogeneity of production batches

en 

2.5/6 rev 1

02/1998

MEDDEV 2.5/9 rev 1 - Medical devices containing natural rubber latex

en 

2.5/9 rev 1

02/2004

MEDDEV 2.7/1 rev 4 - Clinical Evaluation: Guide For Manufacturers And Notified Bodies

en 

2.7/1 rev 4

06/2016

MEDDEV 2.7/2 - Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 93/42/EEC and 90/385/EEC

en 

2.7/2 rev 2

09/2015

MEDDEV 2.7/4 - Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies

en 

2.7/4

12/2010

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

en 

1.19

04/2018

NBOG - Certificates Issued by Notified Bodies Reference to Council Directives 2010-3

en 

2010-3

2010

NBOG - Guidance for Notified Bodies Auditing Suppliers

en 

2010-1

2010

NBOG - Guidance on Audit Report Content

en 

2010-2

2010

 

 

Specific Guidance Documents

Document

Language

Number

Published

EU Commission Regulation 920/2013 on the Designation and Supervision of Notified Bodies

en  fr

920/2013

09/2013

MEDDEV 2.5-7 rev 1 - Discusses conformity assessment for breast implants

en 

2.5-7 rev 1

07/1998

MEDDEV 2.1/2.1 - Computers used to program implantable pulse generators

en 

2.1/2.1

02/1998

MEDDEV 2.1/6 - Qualification and Classification of Stand Alone Software

en 

2.1/6

07/2016

MEDDEV 2.14/4 - CE marking of blood based IVD medical devices for vCJD

en 

2.14/4

01/2012

MEDDEV 2.7/3 - Clinical investigations: serious adverse event reporting

en 

2.7/3

05/2015

 

 

Additional Information

Document

Language

Number

Published

Blue Guide on the implementation of EU product rules

en  fr

C 272/01

07/2016

COMMISSION REGULATION (EU) - E-labeling regulations

en  fr

207/2012

03/2012

EU Commission Recommendation Regarding Unannounced Audits

en  fr

2013/473/EU

09/2013

NBOG - Checklist for audit or Notified Body review of clinical data/evaluation

en 

CL 2010-1

2010