As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2 of my popular articles have worked there way into the annual guide.

THE EU’S MEDICAL DEVICE REGULATION (EU) 2017/745 – ARE YOU READY FOR HUGE SWEEPING CHANGES?

The article now starts off with “Less than 3 Months Left to Implement the EU MDR“. The article was originally written on June 28, 2019, and updated on February 1, 2020.

THE FUTURE OF THE IEC 60601 SERIES: AN UPDATE

“I have been writing and talking about the IEC 60601 series of standards for a very long time, but I have presented on this subject more often in the last couple of years since there is so much changing on a regular basis.” The article was originally written on October 31, 2019, and updated on February 1, 2020.

The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR on 26 May 2020.

Some of the topics to be discussed include:

• Updates on MDCG Subgroups
• MDR/IVDR Implementing Acts
• Commission’s Progress report on Notified Bodies designation process under MDR /IVDR
• EUDAMED db – state of play
• Expert Panels – State of play on setting up of Expert Panels

The MDCG will discuss three transitional provisions:

1. Guidance on significant changes [Art. 120.3 (EU) 2017/745] with regard to devices covered by certificates according to 90/385/EEC or 93/42/EEC – for endorsement
2. Class I transitional provisions in Article 120 (3)(4) – for endorsement
3. Guidance on transitional provisions for consultations of authorities on devices containing ancillary medicinal products and on devices manufactured using TSE susceptible animal tissues – for information

Additionally, some interesting topics include:

• Discussions on the developments with regard to guidance on MDSAP (Medical Device Single Audit Programme)
• EU Participation in the IMDRF (International Medical Devices Regulators Forum)

Draft Agendas are available here: 11 March 2020 – MDCG (MDR/IVDR) High Level – Draft Agenda, 11-12 March 2020 – MDCG (MDR/IVDR) – Draft Agenda, and 12 March 2020 – Meeting between MDCG & Stakeholders MDCG (MDR/IVDR) – Draft Agenda

Need help with regulatory, MDR, quality, or compliance support with IEC 60601 series of standards support please schedule a call.