Se actualizan las guías con las modificaciones del MDR …
interesante revisar la de los clase I: MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devices
| Reference | Title | |
| MDCG 2018-3 Rev.1 | Guidance on UDI for systems and procedure packs | |
| MDCG 2020-14 | Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) | |
| MDCG 2019-10 rev.1 | Application of transitional provisions concerning validity of certificates issued in accordance to the directives | |
| MDCG 2020-13 – Word version | Clinical evaluation assessment report template | |
| MDCG 2020-10/1 MDCG 2020-10/2 |
Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form |
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| MDCG 2019-16 rev.1 | Guidance on cybersecurity for medical devices | |
| MDCG 2019-3 rev.1 | Interpretation of article 54(2)b | |
| MDCG 2020-2 rev.1 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | |
| MDCG 2019-15 rev.1 | Guidance notes for manufacturers of class I medical devices | |