The Medical Device Coordination Group (MDCG) has recently published some updated guidelines as support for the implementation of the new Medical Device Regulations MDR (EU) 2017/745 and the IVDR (EU) 2017/746.

Moreover, it has disclosed the MDCG 2020-14 guideline for Notified Bodies on the use of MDSAP audit reports.

MDCG published updated guidelines and new MDSAP audit
MDCG published updated guidelines and new MDSAP audit

Following the postponement of the application date of the MDR (EU) 2017/745 from the 2020 to the 2021, among the updated guidelines there are:

  • MDCG 2020-2 rev.1 “Class I Transitional provisions under Article 120 (3 and 4) – (MDR)”
  • MDCG 2019-10 rev.1 “Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC”
  • MDCG 2019-15 rev.1 ” Guidance notes for manufacturers of class I Medical Devices”
  • MDCG 2019-16 rev.1 “Guidance on Cybersecurity for Medical Devices”

All documents are available and downloadable from the European Commission website in the section “Guidance – MDCG endorsed documents”.

MDCG 2020-14 MDSAP audit

Issued for the first time, the guideline 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)” explains how Notified Bodies can use MDSAP audit reports during the surveillance audits carried out under the Medical Devices Regulation MDR (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746.

MDSAP program (Medical Device Single Audit Program) allows Auditing Organizations recognized and accredited by the Regulatory Authorities of the five participant countries (USA, Canada, Brazil, Japan and Australia) to conduct a single audit of medical device Manufacturers to ascertain that they meet the quality management requirements (Good Manufacturing Practice – GMP) of the aforementioned countries.

The published guideline is therefore useful if the Manufacturer has been audited by MDSAP and if he would like to present the report in the context of MDR of IVDR surveillance audits.

Discover our services related to CE marking and MDSAP!

Thema offers support for CE certification and services for MDSAP.

For more details, contact us!

Sources:

https://ec.europa.eu/health/md_sector/new_regulations/guidance

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-14-guidance-mdsap_en.pdf