Major Regulations
| Document |
Language |
Number |
Published |
|
* Europe Medical Devices Regulation |
MDR |
05/2017 |
|
|
** Europe IVD Regulation |
IVDR |
05/2017 |
|
|
European Active Implantable Medical Devices Directive (AIMDD) |
90/385/EEC |
06/1990 |
|
|
European Cosmetic Products Directive |
1223/2009 |
11/2009 |
|
|
European In-Vitro Diagnostic Devices Directive (IVDD) |
98/79/EC |
12/2011 |
|
|
European Medical Devices Directive (MDD) |
93/42/EEC |
06/1993 |
|
|
European Personal Protective Equipment Directive |
89/686/EEC |
12/1989 |
|
|
Regulation amending the European MDD 93/42/EEC and others |
2007/47/EC |
9/2007 |
General Guidance Documents
| Document |
Language |
Number |
Published |
|
EU – GHTF Guidelines for Auditing Mfg Control of Supplier – Part 5 |
GHTF/SG4/N84:2010 |
08/2010 |
|
|
EU – GHTF Guidelines for Multi-Site Auditing of QMS Part 4 |
GHTF/SG4/N83:2010 |
08/2010 |
|
|
Interpretation of implementation of Directive 2007/47/EC |
2007/47/EC |
06/2009 |
|
|
MEDDEV 2.1/1 – Defines Medical Devices, Accessories and Manufacturer |
2.1/1 |
04/1994 |
|
|
MEDDEV 2.12-2 rev 2 – Post market clinical follow up for medical devices |
2.12-2 rev 2 |
01/2012 |
|
|
MEDDEV 2.2/1 rev 1 – Addresses EMC requirements |
2.2/1 rev 1 |
02/1998 |
|
|
MEDDEV 2.2/3 rev 3 – Discusses the Use By date |
2.2/3 rev 3 |
06/1998 |
|
|
MEDDEV 2.2/4 – Conformity Assessment of IVF and ART Products |
2.2/4 |
01/2012 |
|
|
MEDDEV 2.4/1 rev 9 – Classification of medical devices |
2.4/1 rev 9 |
06/2010 |
|
|
MEDDEV 2.5/3 rev 2 – When a quality-related inspection of a subcontractor is needed |
2.5/3 rev 2 |
06/1998 |
|
|
MEDDEV 2.1/2 rev 2 – Application of the Active Implantable Device Directive |
2.1/2 rev 2 |
04/1994 |
|
|
MEDDEV 2.1/3 rev 3 – Demarcation between MDD and Medicinal Products Directive |
2.1/3 rev 3 |
12/2009 |
|
|
MEDDEV 2.1/4 – Discusses demarcation between the EMC and PPE Directives |
2.1/4 |
03/1994 |
|
|
MEDDEV 2.1/5 – Addresses medical devices with a measuring function |
2.1/5 |
06/1998 |
|
|
MEDDEV 2.10/2 rev 1 – Designation and monitoring of Notified Bodies |
2.10/2 rev 1 |
04/2001 |
|
|
MEDDEV 2.12-1 rev 8 – Guidelines on a medical devices vigilance system |
2.12-1 rev 8 |
01/2013 |
|
|
MEDDEV 2.14/1 rev 2 – Borderline issues between the IVD and Medical Device Directives |
2.14/1 rev 2 |
01/2012 |
|
|
MEDDEV 2.14/2 rev 1 – Dealing with IVD products for research use only |
2.14/2 rev 1 |
02/2004 |
|
|
MEDDEV 2.14/3 rev 1 – Requirements for e-labeling of IVDs |
2.14/3 rev 1 |
01/2007 |
|
|
MEDDEV 2.15 rev 3 – Committees and organizations related to medical devices |
2.15 rev 3 |
12/2008 |
|
|
MEDDEV 2.5/10 – Guideline For Authorised Representatives |
2.5/10 |
01/2012 |
|
|
MEDDEV 2.5/5 rev 3 – Clarifies translation procedures |
2.5/5 rev 3 |
02/1998 |
|
|
MEDDEV 2.5/6 rev 1 – Defines homogeneity of production batches |
2.5/6 rev 1 |
02/1998 |
|
|
MEDDEV 2.5/9 rev 1 – Medical devices containing natural rubber latex |
2.5/9 rev 1 |
02/2004 |
|
|
MEDDEV 2.7/1 rev 4 – Clinical Evaluation: Guide For Manufacturers And Notified Bodies |
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 |
2.7/2 rev 2 |
09/2015 |
|
|
MEDDEV 2.7/4 – Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies |
2.7/4 |
12/2010 |
|
|
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices |
1.19 |
04/2018 |
|
|
NBOG – Certificates Issued by Notified Bodies Reference to Council Directives 2010-3 |
2010-3 |
2010 |
|
|
NBOG – Guidance for Notified Bodies Auditing Suppliers |
2010-1 |
2010 |
|
|
NBOG – Guidance on Audit Report Content |
2010-2 |
2010 |
Specific Guidance Documents
| Document |
Language |
Number |
Published |
|
EU Commission Regulation 920/2013 on the Designation and Supervision of Notified Bodies |
920/2013 |
09/2013 |
|
|
MEDDEV 2.5-7 rev 1 – Discusses conformity assessment for breast implants |
2.5-7 rev 1 |
07/1998 |
|
|
MEDDEV 2.1/2.1 – Computers used to program implantable pulse generators |
2.1/2.1 |
02/1998 |
|
|
MEDDEV 2.1/6 – Qualification and Classification of Stand Alone Software |
2.1/6 |
07/2016 |
|
|
MEDDEV 2.14/4 – CE marking of blood based IVD medical devices for vCJD |
2.14/4 |
01/2012 |
|
|
MEDDEV 2.7/3 – Clinical investigations: serious adverse event reporting |
2.7/3 |
05/2015 |
Additional Information
| Document |
Language |
Number |
Published |
|
Blue Guide on the implementation of EU product rules |
C 272/01 |
07/2016 |
|
|
COMMISSION REGULATION (EU) – E-labeling regulations |
207/2012 |
03/2012 |
|
|
EU Commission Recommendation Regarding Unannounced Audits |
2013/473/EU |
09/2013 |
|
|
NBOG – Checklist for audit or Notified Body review of clinical data/evaluation |
CL 2010-1 |
2010 |
