S dotazy ke covid-19 se obracejte na celorepublikovou informační linku ke koronaviru 1221.
Pro volání ze zahraničí můžete využít telefonní číslo +420 226 20 1221.

V rámci opatření proti koronavirové nákaze upřednostněte, prosím, písemný, elektronický či telefonický kontakt před osobním setkáním na ministerstvu.

Doporučující a interpretační dokumenty MEDDEV

Vytvořeno: 19. 2. 2016 Poslední aktualizace: 19. 2. 2016

Doporučující a interpretační dokumenty MEDDEV

Aplikace směrnic a definice
MEDDEV 2.1/1 Definitions of „medical devices“, „accessory“ and „manufacturer“
MEDDEV 2.1/2 rev. 2 Field of application of directive „active implantable medical devices“ 
MEDDEV 2.1/2.1 Field of application of directive „active implantable medical devices“
MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative
MEDDEV 2.1/4 Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment

  • 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

MEDDEV 2.1/5 Medical devices with a measuring function
MEDDEV 2.1/6 Qualification and Classification of stand-alone software

Základní požadavky
MEDDEV 2.2/1 rev.1 EMC requirements
MEDDEV 2.2/3 rev.3 „Use by“ – date
MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART) products

Klasifikace zdravotnického prostředku
MEDDEV 2.4/1 rev.9 Classification of medical devices

Proces posuzování shody
General rules
Quality assurance. Regulatory auditing of quality systems of medical device manufacturers (See document in the GHTF-Global Harmonization Task Force website)
MEDDEV 2.5/3 rev.2 Subcontracting quality systems related
MEDDEV 2.5/5 rev.3 Translation procedure
MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers‘ products)

Conformity assessment for particular groups of products
MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants
MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex
MEDDEV 2.5/10 Guideline for Authorized Representatives

Klinické zkoušky a klinické hodnocení
MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies
MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation notification
MEDDEV 2.7/3 Clinical investigations: serious adverse under directives 90/385/EEC and 93/42/EC – SAE reporting form
MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies

Notifikované osoby
MEDDEV 2.10/2 rev.1  Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices

Výrobky využívající materiály biologického původu
MEDDEV 2.11/1 rev.2 Application of Council Directive 93/42/EEC taking into account the Commission Directive 2003/32/EC for Medical Devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected Annex 1

Následný dozor a systém vigilance
MEDDEV 2.12/1 rev.8 Medical Devices Vigilance System Manufacturer Incident Report How to use the MIR
MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies

Přechodné období
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)

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

IVD
MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies
MEDDEV 2.14/2 rev.1 Research Use Only products
MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices

  • Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10

MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP

Ostatní
MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device Directives

Doporučující dokumenty MEDDEV lze nalézt na webu Evropské Komise (http://ec.europa.eu/growth/sectors/medical-devices/guidance/index_en.htm)