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 | 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 |
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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 |