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TITLE of MEDDEV - NB DOCUMENT / TITULO del DOCUMENTO MEDDEV NB |
MEDDEV
NB |
1. DIRECTIVES / DIRECTIVAS |
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1.1 AIMDD |
Directive
90/385/EEC on active implantable medical devices (AIMD) as amended by directive 2007/47/EC
Directiva 90/385/EEC de productos sanitarios implantables activos (PSIAI) modificada por la dir. 2007/47/EC |
NA |
|
1.2 MDD |
Directive
93/42/EEC on medical devices (MDD) as amended by directive 2007/47/EC
Directiva 93/42/EEC de productos sanitarios implantables activos (PSIAI) modificada por la dir. 2007/47/EC |
NA |
|
revision |
|
NA |
|
1.3 IVDMDD |
Directive
98/79/EEC on in vitro diagnostic medical devices (IVDMD)
Directiva 98/79/EC de productos sanitarios para diagnostico in vitro (PSDIV) |
NA |
|
revision |
|
NA |
2. GUIDANCE DOCUMENTS / GUIAS |
|
2.1
Scope,
field of application,
definitions
Alcance, campo de aplicación, definiciones |
Definitions
of "medical devices", "accessory" and
"manufacturer" |
2.1/1
April-1994 |
| Field
of application of directive "active implantable medical
devices" |
2.1/2 rev 2
April-1994 |
| Treatment
of computers used to program implantable pulse
generators |
2.1/2.1
Feb-1998 |
Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative  |
2.1/3 rev
3
Dec 2009 |
| Interface
with other directives - Medical
devices/directive89/336/EEC relating to electromagnetic
compatibility and directive 89/686/EEC relating to
personal protective equipment |
2.1/4
Mar-1994 |
| Medical
devices with a measuring function |
2.1/5
Jun-1998 |
| Qualification and Classification of stand alone software |
2.1/6
Jan 2012 |
|
Representative
sample |
2.1/Rec1 |
|
Explanation
of terms |
2.1/Rec2 |
|
Accessories
and other parts for AIMD |
2.1/Rec3 |
|
Medical
devices with a measuring function |
2.1/Rec4 |
|
Placing
on the market of fully refurbished medical devices |
2.1/Rec5 |
|
2.2
Essential requirements
Requisitos Esenciales |
EMC
requirements
NB-MED EMC
requirements |
2.2/1 rev
1
Feb-1998
2.2/Rec1 |
| "Use
by" - date |
2.2/3 rev
3
Jun-1998 |
|
Treatment
of computer used to program Active Implantable Medical |
2.2 /Rec2
|
|
Software
and Medical Devices |
2.2/Rec4 |
|
Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products |
2.2/4
Jan-2012 |
2.3
Reference to standards
Referencias a normas |
Publication
of titles and references of european harmonized
standards under AIMD and MDD |
2.3/1 |
|
2.4
Classification of MD
Clasificación PS |
Guidelines to the
classification of medical devices |
2.4/1 rev.9
Jun-2010 |
|
Manual Borderline Classification & MD
|
ver. 1.11
Dec-2011 |
|
Manual Borderline Classification & MD
|
ver. 1.12
Apr-2012 |
2.5
Conformity assessment
procedure General rules Procedimiento de evaluación Reglas generales
|
|
Content of mandatory certificates
|
2.5.1/Rec4 |
|
Technical
documentation
|
2.5.1/Rec5 |
|
Renewal of
EC Design- Examination and type-Examination certificates |
2.5.1/Rec6 |
|
Quality
assurance Regulatory auditing of quality systems of
medical devices manufacturers |
2.5/2 rev 3
Jun 1998 |
|
Subcontracting quality system related |
2.5/3 rev.2
Jun-1998 |
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Reporting of design changes and of changes of the
quality system
|
2.5.2/Rec2 |
|
Translation
procedure
|
2.5/5
rev.3
feb 1998 |
|
Homogenous
batches (verification of manufacturers’
products) |
2.5/6
rev.1
feb 1998 |
2.5
Conformity assessment
procedure
Conformity
assessment for particular groups of products
Procedimiento de evaluacion |
Conformity
assessment of breast implants |
2.5/7
rev.1
Jul-1998 |
|
Evaluation
of medical devices incorporating products of animal
origin |
2.5/8
rev.2
Feb-1999 |
|
Evaluation
of medical devices incorporating products containing
natural rubber latex |
2.5/9 rev1
Feb-2004 |
|
Guidelines for Authorised Representatives |
2.5/10
Jan-2012 |
|
2.5.2
Quality assurance
Aseguramiento Calidad |
Subcontracting- QS related |
2.5.2/Rec1 |
|
Reporting of design changes and changes of quality
system |
2.5.2/Rec2 |
|
Translation procedure |
2.5.2/Rec3 |
2.5.3
Type examination
Examen de tipo |
|
|
2.5.4
Verification of manufactured products |
Homogeneous batches |
2.5.4/Rec1 |
|
Verification
of manufacture products for IVD directive |
2.5.4/Rec2 |
|
2.5.5
Conformity assessment for particular
product groups |
Conformity assessment procedures of
breast implants |
2.5.5/Rec1 |
|
Combination of CE marked and non CE marked medical
devices and non-medical devices |
2.5.5/Rec2 |
|
Conformity
assessment of annex II, IVD designed and evaluated
prior to adoption of CTS |
2.5.5/Rec3 |
|
Assessment
of sensitivity of IVD Medical devices- Guidance on the
application of the CTS |
2.5.5/Rec4 |
2.6
CE marking |
|
|
2.7
Clinical investigation, clinical
evaluation |
Clinical evaluation: Guide for manufacturers and notified bodies |
2.7.1 Rev3
Dec 2009 |
| Appendix 1: Clinical evaluation on coronary stents |
Dec 2008 |
| Guide for Competent Authorities in making an assessment of clinical investigation; notification |
Dec 2008 |
| Guide for Competent Authorities in making an assessment of clinical investigation |
2.7/2
Dec 2008 |
| Clinical investigations: Serous adverse event reporting |
2.7/3
Dec 2010 |
| Guidelines on clinical Investigations: a guide for manufacturers and notified bodies |
2.7/4
Dec 2010 |
2.8
Devices intended for special purposes |
|
|
2.9
Systems and procedure packs |
|
|
2.10
Notified bodies |
Designation
and monitoring of Notified Bodies within the framework
of EC Directives on Medical devices
Annex
1
Annex
2
Annex
3
Annex
4 |
2.10/2 rev. 1
Apr-2001 |
| |
|
2.11
Products using materials
of biological origin |
Application of
council Directive 93/42/EEC taking into account the
Commission
Directive
2003/32/EC for Medical Devices utilizing tissues or
derivatives originating from animals for which a TSE risk
is suspected |
2.11/1 rev.1
Feb-2004 |
|
Annex 1 |
2.12
Market surveillance ; vigilance |
Guidelines on a medical devices vigilance system |
2.12/1
rev 7
Mar-2012 |
|
Medical
devices vigilance System |
2.12/1 rev.6
Dec 2009 |
| Appendix,
list of contact points |
2.12/1 rev
4
nov 2001 |
| Clinical
Evaluation - Post Market Clinical Follow-up |
2.12/2
may 2004
|
| Post Market Clinical Follow-up studies |
2.12/2 rev 2 Jan-2012 |
|
Post-Marketing
Surveillance (PMS) post market/production |
2.12/Rec1 |
|
2.13
Transitional period |
OJ
C242 of August 8, 1998
|
2.13 rev.1 |
|
CE-Marking of pre-MDD devices |
2.13/Rec1 |
|
CE-Marking of
established IVD devices |
2.13/Rec2 |
2.14
Implementation |
Implementation of AIMD
Directive into national law -- Real Decreto 1616/2009 english |
|
| Implementation of MD
Directive into national law - Real Decreto 1591/2009 english |
|
| Implementation of IVDMD
Directive into national law - Real Decreto 1662/2000 english |
|
|
2.14
IVD |
Borderline issues |
2.14/1 rev.1
Jan-2004 |
|
Research Use Only products |
2.14/2 rev.1
Feb-2004 |
|
Supply of
Instructions For Use (IFU) and other information for
In-vitro Diagnostic (IVD) Medical Devices
|
2.14/3 rev.1
Jan - 2007 |
| CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP
|
2.14/4
Jan-2012 |
|
2.15
Other
guidance |
Committees,
working parties relevant for medical
devices |
2.15 rev.2
Jul-2001 |
|
Global
Harmonization Task Force |
6/94
p.1
6/94 p.2 |
|
Voluntary
certification at an intermediate stage of manufacture |
2.15/Rec1 |
3. CONSENSUS
STATEMENTS / DOCUMENTACION CONSENSUADA |
| “Consensus
statements“
on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC |
NB-MED CONSENSUS STATEMENTS
completed
by comments of the Notified Body Recommendations Group -
NBRG
Issue 01/2003
The "consensus statements“ :
(i) reflect consensus of those
present / represented at the time of the relevant
meeting
Note:
Opinion may change in the light of experience and
/ or detailed consideration of the issue, for example,
by those involved in drafting „Recommendations“ in
the area, and thus a particular „statement“ may be
superseded.
(ii)
may take the form of questions and answers, often
qualified in relation to specific circumstances,
products etc.
Note: The answer given may not be appropriate to other circumstances,
products etc.
(iii)
will include text in italics below each
„statement“
(a)
indicating the actions agreed as necessary that
are planed or have been taken
(b)
referring to specific relevant NB-MED "Recommendation (s)“
in the area
(c)
indicating where a "statement“ has been
superseded, with appropriate cross-references |
NBRG/276/03
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|
MDEG CONSENSUS STANDARDS |
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|
Guidance document on Dir. 2005/50/EC |
Dec 2006 |
|
IVD Trisomy 21
|
Dec 2006 |
|
IVD Rare
Blood Groups |
Dec 2003 |
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4. NBOG DOCUMENTS / DOCUMENTACIÓN NBOG |
NBOG’s Best Practice Guide
|
NBOG BPG 2006-1 Change of Notified Body |
Nov 2008 |
|
NBOG BPG 2009-3 Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment |
Mar 2009 |
|
NBOG BPG 2009-1 Guidance on Design-Dossier Examination and Report Content |
Mar 2009 |
|
NBOG BPG 2009-4 Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis |
Jul 2009 |
| 5. CMC's DOC's |
| CMC Docs |
|
|
| 6. GHTF's DOC's |
| GHTF reference docs |
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| 7. AWPS's DOC's |
| GHTF reference docs |
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| 7. IAF DOC's |
| IAF reference documents |
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