Documentos MDCG
|
Titulo |
Publicación |
Fecha |
| 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 |
Clasificación
Normativa aplicable
Seguimiento postcomercialización
