Manufacturers outside the Union — including every UK manufacturer since Brexit — need an EU Authorised Representative (sometimes still called an "EC REP") to place devices on the EU market. Axiom Biotek acts as your AR from Sweden, under a documented quality system with a qualified PRRC.
Unlike letterbox providers, we verify your technical documentation before we put our name on your label — and because we're consultants first, the gaps we find are gaps we can help you close.
Since May 2026, Eudamed registration is mandatory alongside the AR mandate itself.
Devices already on the EU market must be registered in Eudamed. If your AR arrangements aren't settled, now is the time.
Talk to us about EU representationWe work with manufacturers who don't yet have an EU presence — mapping what you already hold under your home regime onto what MDR/IVDR requires, rather than starting from zero.
Sets out what an Authorised Representative must do: verify technical documentation, keep it available for competent authorities, and register as the responsible economic operator.
Governs how a mandate transfers between representatives — the outgoing and incoming AR, and the manufacturer, all have defined obligations to keep coverage continuous.
Requires a Person Responsible for Regulatory Compliance with defined qualifications — a role we support alongside the AR mandate.
A legal entity established in the EU that a non-EU manufacturer mandates to act on its behalf under Article 11. The AR verifies technical documentation, keeps it available to competent authorities, and registers as the responsible economic operator. The role is still sometimes called an "EC REP" — a term carried over from the pre-2017 Medical Device Directives.
Yes. The UK is a third country under MDR/IVDR, so any UK manufacturer placing devices on the EU market needs an EU Authorised Representative — separate from, and in addition to, the UK Responsible Person required for the GB market.
Devices already on the EU market that haven't yet been registered in Eudamed must be by 28 November 2026. If your AR arrangements aren't settled, that's the date to work backward from.
No — distinct roles. The Authorised Representative (Article 11) is the EU-based legal entity representing a non-EU manufacturer; the PRRC (Article 15) is the individual responsible for regulatory compliance. Axiom Biotek supports both.
Yes — Article 12 sets out how a mandate transfers between representatives, with defined obligations for the outgoing AR, incoming AR and manufacturer so cover stays continuous. We handle transfers as part of onboarding.
Tell us where your manufacturing and technical documentation stand today — we'll tell you honestly what an Article 11 mandate with us would look like.
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