EU/UK Regulatory Status

Last updated: 2026-09-06

Why no CE mark yet?

Under EU Regulation 2017/745 (MDR) and the UK Medical Devices Regulations 2002, standalone software that provides information used for diagnostic or therapeutic decisions (for example an IOL power calculator, an Amsler-grid interpretation aid, or a myopia progression risk calculator) is generally classified as a Class IIa medical device under MDR Annex VIII Rule 11.

For a Class IIa software device, the legal pathway in the EU requires:

  • An EU Authorised Representative based in an EU member state.
  • Registration of the device in EUDAMED.
  • A conformity assessment by a Notified Body (third-party audit) — including a Clinical Evaluation Report, a Post-Market Surveillance plan, a Summary of Safety and Clinical Performance, and full ISO 13485-style quality management.
  • A CE mark and UDI carrier on the product and labelling.

These steps are a meaningful investment of time and money (typically USD 50k-200k in Notified Body fees and consultant costs, plus 6-12 months of work) for a small, free, independently run educational tool.

What this means for you in the EU / EEA / UK / Switzerland

The site remains available to browse in the EU and UK — we do not block traffic — but we are not actively marketing these tools as medical devices within the EEA or the UK.

EU and UK users may continue to use the calculators for personal education. They remain free, vendor-neutral, peer-reviewed, and explicitly not medical advice. They do not replace a consultation with a licensed eye-care professional.

What we are doing about it

  • We display a regional notice at the top of every page for visitors in the EU/EEA/UK/CH.
  • We are evaluating options for an EU Authorised Representative and a Class IIa conformity assessment under MDR Rule 11.
  • We will update this page when the regulatory status changes.

References

  • Regulation (EU) 2017/745 (Medical Devices Regulation), Annex VIII, Rule 11.
  • UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended), Annex IX.
  • MDCG 2019-11 — Guidance on Qualification and Classification of Software under MDR/IVDR (current revision: Rev.1, June 2025).
  • MHRA "Medical device stand-alone software including apps (including IVDMDs)" guidance, v1.10f.

Effective date: 2026-09-20