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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
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