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Documentos MDCG

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Publicación

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MDCG 2019-16 Guidance on Cybersecurity for medical devices Dic 2019
MDCG 2019-15 Guidance notes for manufacturers of class I medical devices Dic 2019
MDCG 2019-14 Explanatory note on MDR codes Dic 2019
MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation Dic 2019
MDCG 2019-12 Designating authority’s final assessment form: Key information (EN) Oct 2019
MDCG 2019-11 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 Oct 2019
MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to the directives Oct 2019
MDCG 2019-09 Summary of safety and clinical performance Agost 2019
MDCG 2019-08 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices Jun 2019
MDCG 2019-07 Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) Jun 2019
MDCG 2019-06 v2 Questions and answers: Requirements relating to notified bodies Oct 2019
MDCG 2019-05 Registration of legacy devices in EUDAMED Abr 2019
MDCG 2019-04 Timelines for registration of device data elements in EUDAMED Abr 2019
MDCG 2019-03 Interpretation of article 54(2)b Mar 2019
MDCG 2019-02 Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 Feb 2019
MDCG 2019-01 MDCG guiding principles for issuing entities rules on basic UDI-DI En 2019
MDCG 2018-08 Guidance on content of the certificates, voluntary certificate transfers Nov 2018
MDCG 2018-07 Provisional considerations regarding language issues associated with the UDI database Oct 2018
MDCG 2018-06 Clarifications of UDI related responsibilities in relation to article 16 October 2018
MDCG 2018-05 UDI assignment to medical device software October 2018
MDCG 2018-04 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs October 2018
MDCG 2018-03 Guidance on UDI for systems and procedure packs October 2018
MDCG 2018-02 Future EU medical device nomenclature – Description of requirements March 2018
MDCG 2018-01 v2 Guidance on basic UDI-DI and changes to UDI-DI February 2019