Guidelines relating to Medical Devices EU legislation

We present here a compendium of guidance documents as 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.

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.

DIRECTIVES

1.Directives

1.1 AIMDD

small-pdf-logoDirective 90/385/EEC on active implantable medical devices (AIMD) as amended by directive 2007/47/EC

1.2 MDD

small-pdf-logoDirective 93/42/EEC on medical devices (MDD) as amended by directive 2007/47/EC

1.3 IVDMDD

small-pdf-logoDirective 98/79/EEC on in vitro diagnostic medical devices (IVDMD)

2. Guidance Documents

2.1 Scope, field of application, definition

small-pdf-logoMEDDEV 2.1/1 (18 kB) Definitions of “medical devices”, “accessory” and “manufacturer” April 1994

small-pdf-logoMEDDEV 2.1/2 rev.2 (14 kB) Field of application of directive “active implantable medical devices” April 1994

small-pdf-logo MEDDEV 2.1/2.1 (12 kB) Treatment of Computers Used to Program Implantable Pulse Generators February 1998

small-pdf-logoMEDDEV 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

small-pdf-logoMEDDEV 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)

small-pdf-logoMEDDEV 2.1/5 (10 kB) Medical devices with a measuring function June 1998

small-pdf-logoMEDDEV 2.1/6 (325 kB) Qualification and Classification of stand alone software July 2016

2.2 Essential requirements

small-pdf-logoMEDDEV 2.2/1 rev.1 (16 kB) EMC requirements February 1998

small-pdf-logoMEDDEV 2.2/3 rev.3 (17 kB) “Use by”-date June 1998

small-pdf-logoMEDDEV 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

small-pdf-logoMEDDEV 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

small-pdf-logo (See document in the GHTF-Global Harmonization Task Force)

small-pdf-logoMEDDEV 2.5/3 rev.2 (8 kB) Subcontracting quality systems related June 1998

small-pdf-logoMEDDEV 2.5/5 rev.3 (7 kB) Translation procedure February 1998

small-pdf-logoMEDDEV 2.5/6 rev.1 (9 kB) Homogenous batches (verification of manufacturers’ products) February 1998

Conformity assessment for particular groups of products

small-pdf-logoMEDDEV 2.5/7 rev.1 (92 kB) Conformity assessment of breast implants July 1998

small-pdf-logo MEDDEV 2.5/9 rev.1 (96 kB) Evaluation of medical devices incorporating products containing natural rubber latex February 2004

small-pdf-logoMEDDEV 2.5/10 (80 kB) Guideline for Authorised Representatives January 2012

2.7 Clinical investigation, clinical evaluation

small-pdf-logoMEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies June 2016

small-pdf-logoAppendix 1: Clinical evaluation on coronary stents (100 kB) December 2008

small-pdf-logoMEDDEV 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

small-pdf-logoMEDDEV 2.7/3 rev. 3 (166 kB) Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC

small-pdf-logoSAE reporting form (87 kB) May 2015

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

small-pdf-logoMEDDEV 2.7/4 (183 kB) Guidelines on Clinical investigations: a guide for manufacturers and notified bodies December 2010

2.10 Notified bodies

small-pdf-logoMEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices

small-pdf-logoAnnex 1 (119 kB),

small-pdf-logoAnnex 2 (14 kB),

small-pdf-logoAnnex 3 (16 kB),

small-pdf-logo Annex 4 (26 kB)

2.12 Market surveillance

small-pdf-logoMEDDEV 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

small-pdf-logoHow to use FSCA and MIR forms (12 kB

small-pdf-logoManufacturer Incident Report – MIR (971 kB)

small-pdf-logoField Safety Corrective Action – FSCA (1 MB)

MIR and FSCA xml files

Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there.

Other forms and templates

small-pdf-logoField Safety Notice Template (27 kB)

small-pdf-logoTrend Report (151 kB)

small-pdf-logo Periodic Summary Report (192 kB)

EU Vigilance Pilot on Trending – Additional MIR Form

small-pdf-logoEU Vigilance Pilot MIR form

small-pdf-logoEU Vigilance Pilot MIR Step-by-Step Guide (236 kB)

small-pdf-logoEU Vigilance Pilot Toolkit for Users (23 kB)

Ⅱ. Device Specific Vigilance Guidance

small-pdf-logoDSVG Template (22 kB)

small-pdf-logo DSVG 00 (20 kB) Introduction to Device Specific Vigilance Guidance

small-pdf-logoDSVG 01 (96 kB) Cardiac Ablation Vigilance Reporting Guidance

small-pdf-logoDSVG 02 (99 kB) Coronary Stents Vigilance Reporting Guidance

small-pdf-logoMEDDEV 2.12/2 rev.2 (228 kB) Post Market Clinical Follow-up studies January 2012

2.13 Transitional period

small-pdf-logo MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) August 1998

As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission’s services of 5 June 2009 (35 kB)

2.14 IVD

small-pdf-logoMEDDEV 2.14/1 rev.2 (76 kB) Borderline and Classification issues. A guide for manufacturers and notified bodies January 2012

small-pdf-logoMEDDEV 2.14/2 rev.1 (64 kB) Research Use Only products February 2004

small-pdf-logo 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

small-pdf-logo Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device
Directive, Article 10 (213 kB) January 2007

small-pdf-logoMEDDEV 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

small-pdf-logoMEDDEV 2.15 rev.3 (32 kB) Committees/Working Groups contributing to the implementation of the Medical Device Directives December 2008

MEDICAL DEVICES REGULATION

REGLAMENTOS PRODUCTOS SANITARIOS

RPS

RIVD

NBOG

USEFUL LINKS

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

IMDRF (ex GHTF) http://www.imdrf.org

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