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DIRECTRICES SOBRE LA LEGISLACION EU DE PRODUCTOS SANITARIOS

Presentamos aquí un compendio de documentos de guía tales como los 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.


 1.DIRECTIVAS / DIRECTIVES

1.1 AIMDD

  • Directiva 90/385/EEC on active implantable medical devices (AIMD) as amended by directive 2007/47/EC

1.2 MDD

  • Directive 93/42/EEC on medical devices (MDD) as amended by directive 2007/47/EC

1.3 IVDMDD

  • Directive 98/79/EEC on in vitro diagnostic medical devices (IVDMD)

2. GUIAS / GUIDANCE DOCUMENTS

2.1 SCOPE, FIELD OF APPLICATION, DEFINITION

  • MEDDEV 2.1/1 (18 kB) Definitions of “medical devices”, “accessory” and “manufacturer” April 1994
  • MEDDEV 2.1/2 rev.2 (14 kB) Field of application of directive “active implantable medical devices” April 1994
  • MEDDEV 2.1/2.1 (12 kB) Treatment of Computers Used to Program Implantable Pulse Generators February 1998
  • MEDDEV 2.1/3 rev.3 (183 kB) Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative December 2009
  • MEDDEV 2.1/4 (21 kB) Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment March 1994

For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009 (28 kB)

  • MEDDEV 2.1/5 (10 kB) Medical devices with a measuring function June 1998
  • MEDDEV 2.1/6 (325 kB) Qualification and Classification of stand alone software July 2016

2.2 ESSENTIAL REQUIREMENTS

  • MEDDEV 2.2/1 rev.1 (16 kB) EMC requirements February 1998
  • MEDDEV 2.2/3 rev.3 (17 kB) “Use by”-date June 1998
  • MEDDEV 2.2/4 (38 kB) Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products January 2012

2.4 CLASSIFICATION OF MD

  • MEDDEV 2.4/1 rev.9 (759 kB) Classification of medical devices June 2010

2.5 CONFORMITY ASSESSMENT PROCEDURE GENERAL RULES

Quality assurance. Regulatory auditing of quality systems of medical device manufacturers

  • (See document in the GHTF-Global Harmonization Task Force)
  • MEDDEV 2.5/3 rev.2 (8 kB) Subcontracting quality systems related June 1998
  • MEDDEV 2.5/5 rev.3 (7 kB) Translation procedure February 1998
  • MEDDEV 2.5/6 rev.1 (9 kB) Homogenous batches (verification of manufacturers’ products) February 1998

Conformity assessment for particular groups of products

  • MEDDEV 2.5/7 rev.1 (92 kB) Conformity assessment of breast implants July 1998
  • MEDDEV 2.5/9 rev.1 (96 kB) Evaluation of medical devices incorporating products containing natural rubber latex February 2004
  • MEDDEV 2.5/10 (80 kB) Guideline for Authorised Representatives January 2012

2.7 CLINICAL INVESTIGATION, CLINICAL EVALUATION

  • MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies June 2016
  • Appendix 1: Clinical evaluation on coronary stents (100 kB) December 2008
  • MEDDEV 2.7/2 rev. 2 (37 kB) Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC September 2015
  • MEDDEV 2.7/3 rev. 3 (166 kB) Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC
  • SAE reporting form (87 kB) May 2015

The new SAE reporting form will be taken in use 1 September 2016 at the latest.

  • MEDDEV 2.7/4 (183 kB) Guidelines on Clinical investigations: a guide for manufacturers and notified bodies December 2010

2.10 NOTIFIED BODIES

  • MEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices
    • Annex 1 (119 kB),
    • Annex 2 (14 kB),
    • Annex 3 (16 kB),
    • Annex 4 (26 kB)

2.12 MARKET SURVEILLANCE

  • MEDDEV 2.12/1 rev.8 (763 kB) Guidelines on a Medical Devices Vigilance System January 2013
    • Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms
    • MEDDEV 2.12/1 rev. 7 MIR and FSCA are still valid
    • Active PDF forms
    • How to use FSCA and MIR forms (12 kB
  • Manufacturer Incident Report – MIR (971 kB)
  • Field Safety Corrective Action – FSCA (1 MB)
  • MIR and FSCA xml files

Other forms and templates

  • Field Safety Notice Template (27 kB)
  • Trend Report (151 kB)
  • Periodic Summary Report (192 kB)

EU Vigilance Pilot on Trending – Additional MIR Form

  • EU Vigilance Pilot MIR form
  • EU Vigilance Pilot MIR Step-by-Step Guide (236 kB)
  • EU Vigilance Pilot Toolkit for Users (23 kB)

Ⅱ. Device Specific Vigilance Guidance

  • DSVG Template (22 kB)
  • DSVG 00 (20 kB) Introduction to Device Specific Vigilance Guidance
  • DSVG 01 (96 kB) Cardiac Ablation Vigilance Reporting Guidance
  • DSVG 02 (99 kB) Coronary Stents Vigilance Reporting Guidance
  • MEDDEV 2.12/2 rev.2 (228 kB) Post Market Clinical Follow-up studies January 2012

2.13 TRANSITIONAL PERIOD

 

2.14 IVD

  • MEDDEV 2.14/1 rev.2 (76 kB) Borderline and Classification issues. A guide for manufacturers and notified bodies January 2012
  • MEDDEV 2.14/2 rev.1 (64 kB) Research Use Only products February 2004
  • MEDDEV 2.14/3 rev.1 (80 kB) Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices January 2007
  • Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device
    Directive, Article 10 (213 kB) January 2007
  • MEDDEV 2.14/4 (114 kB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012

2.15 OTHER GUIDANCES

 

NBOG

  • NBOG BPG 2016-1(Re-)designation of notified bodies: Process for joint assessments Jun 2016
  • NBOG BPG 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System 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 2014-1 Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules Nov 2014
  • 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 2010-2 Guidance on Audit Report Content Mar 2010
  • NBOG BPG 2010-1 Guidance for Notified Bodies auditing suppliers to medical device manufacturers Mar 2010
  • NBOG BPG 2009-4 Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis Jul 2009
  • NBOG BPG 2009-3 Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment
  • NBOG BPG 2009-2 Role of Notified Bodies in the Medical Device Vigilance System Mar 2009
  • NBOG BPG 2009-1 Guidance on Design-Dossier Examination and Report Content Mar 2009
  • NBOG_BPG_2006-1 Change of Notified Body Nov 2008

USEFUL LINKS

MEDICAL DEVICES NET – TECNOLOGÍAS SANITARIAS https://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 http://www.cmc-md.eu

IMDRF (ex GHTF) http://www.imdrf.org

NB-MED http://www.team-nb.org


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