IVDR – Eisner Safety Consultants

EN 60601-1 Harmonised, and “EC REP” Becomes “EU REP”: Annex ZZ, State of the Art, and the MDR Questions the Headlines Skipped

After the Official Journal harmonised EN 60601-1 on 17 June 2026, I later wrote up an overview: what changed, the nine-year wait, what to cite, and the EC REP to EU REP switch riding alongside it. Then the comments started, and the good ones went straight past the headline. This is the deeper cut.
This post assumes you already know that EN 60601-1:2006/A13:2024 landed at entry No. 65 and that A13 carries Annex ZZ. From here I want to answer the questions my readers actually asked. I have deliberately not repeated much of what is already in the LinkedIn article, which covers the background, the full decision, and several points I do not revisit here, so it is worth reading alongside this.

Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines

Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions

Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.

Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays

Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

Draft EUDAMED Roadmap of Modules

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

Regulatory Updates – January 2022

Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world

EU MDR & IVDR Harmonized Standards Lists Updated – 9 Added to MDR & 5 to IVDR

The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746on 5 January 2022 and 7 January 2022 amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195 all above references are

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