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Guidelines relating to

Medical Devices Directives

We present here a compendium of MEDDEV  and NBMED documents for your info.

These  guidelines have been elaborated through a process of consultation with  Competent Authorities and Commission representatives, Notified Bodies, industry and other interested parties in the medical devices sector

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process.

We also follow here the new documents result of the meetings of experts.

 Please return frequently to be up to date.

Guías de las

Directivas de Productos Sanitarios

Presentamos aquí un compendio de los documentos MEDDEV  y NBMED para su información.

Estas guías han sido elaboradas vía un proceso de consultas con las Autoridades Competentes y representantes de la Comisión, Organismos Notificados, la industria y otras partes interesadas en el sector de productos sanitarios.

Debido a la participación de las  mencionadas partes interesadas y de expertos de las Autoridades Competentes, se prevé que estas directrices se seguirán en los Estados Miembros y por lo tanto, asegura una aplicación uniforme de las disposiciones de la directiva. Las Guías están sujetas a un proceso regular de actualización.

Seguimos ,además, aquí los nuevos documentos resultado de las reuniones de los expertos.

 Por favor, vuelva frecuentemente para estar al día.

 

 

TITLE of MEDDEV - NB DOCUMENT  /  TITULO del DOCUMENTO MEDDEV NB

MEDDEV
NB

1. DIRECTIVES / DIRECTIVAS

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

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 8
Jan-2013
Appendix, list of contact points   2.12/1 rev 4
nov 2001
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   
Implementation of MD Directive into national law  - Real Decreto 1591/2009   
Implementation of IVDMD Directive into national law - Real Decreto 1662/2000   

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

MDEG CONSENSUS STANDARDS  
Guidance document on Dir. 2005/50/EC Dec 2006
IVD Trisomy 21 Dec 2006
IVD Rare Blood Groups Dec 2003
   

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
NBOG BPG 2010-1  Guidance for Notified Bodies auditing suppliers to medical device manufacturers Mar 2010
NBOG BPG 2010-2  Guidance on Audit Report Content  Mar 2010
NBOG BPG 2010-3  Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC Mar 2010
NBOG BPG 2014-1  Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules Nov 2014
NBOG BPG 2014-2  Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities  Nov  2014
NBOG BPG 2014-3  Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System Nov  2014
5. CMC's
CMC Docs http://www.cmc-md.eu/decisions.html  
6. IMDRF (GHTF's)
GHTF reference doc's
IMDRF doc's

http://www.imdrf.org/ghtf/ghtf-archived-docs.asp

http://www.imdrf.org/documents/documents.asp

 
7. AHWP
AHWP's reference docs http://www.ahwp.info/

http://www.ahwp.info/index.php?q=node/151

 
8. AEMPS Spanish Medicine and Medical Devices Agency
AEMPS reference documents http://www.aemps.gob.es/productosSanitarios/prodSanitarios/home.htm  

 

 

USEFUL LINKS / ENLACES ÚTILES

 

Medical Devices Net - Tecnologias Sanitarias  http://www.tecnologias-sanitarias.com

MEDDEV   http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

MEDICAL DEVICES http://ec.europa.eu/health/medical-devices/index_es.htm 

AEMPS    http://www.aemps.gob.es/ - Productos Sanitarios http://www.aemps.gob.es/productosSanitarios/portada/home.htm

SEEIC  http://www.seeic.org

NBOG  http://www.nbog.eu 
CMC www.cmc-md.eu/
IMDRF (ex GHTF) http://www.imdrf.org/
AWPS
NB-MED  http://www.team-nb.org/

 

Last update / Ultima actualización: 2015-03-18

For technical questions regarding medical devices & Technologies, please visit our corporate website  www.tecno-med.es
 for questions about this website  contact info@tecno-med.es  

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