Situation 03A new regulation or an audit
A regulator is coming, or a new rule now applies to us
An audit is announced, or a regime such as the EU AI Act or a sector rule now covers the company. The work is to find the gaps before the inspector does.
In short
- At stake
- The approval the business runs on, and what the audit finds.
- The exposure
- The gaps are found by the inspector, and they are fixed under the regulator's deadline instead of your own.
- What Lexaero delivers
- A ranked list of gaps and a costed plan, then documents your teams can follow and an inspector can audit, fitted into the management system you already run.
- First step
- The Diagnostic, a three-week assessment at a fixed fee. Where the regime is outside Lexaero's own sector experience, a specialist named in the proposal works alongside Lexaero.
Country by country
General orientation as at October 2026. It is not legal advice, and what applies to you turns on facts this page cannot see.
Sector regulation
- In the EU
- Regulated products need a footing in the EU. A medical-device manufacturer outside it, for example, must appoint an authorised representative established in the EU. Regulated services generally need an authorisation in a member state.
- In Switzerland
- Switzerland runs its own regimes beside the EU's. A foreign medical-device manufacturer needs a Swiss authorised representative, while in some sectors Switzerland applies the EU rules directly.
- In the United Kingdom
- Great Britain has its own registration and marking rules. A medical-device manufacturer outside the United Kingdom, for example, needs a UK Responsible Person.
AI governance
- In the EU
- The EU AI Act applies to providers and deployers in the EU, and to those outside it when the output of a system is used in the EU. AI-literacy and transparency duties already apply. The high-risk obligations follow from 2 December 2027, and from 2 August 2028 for AI built into regulated products.
- In Switzerland
- Switzerland has no AI act of its own. Existing law applies, data protection first, and a Swiss company comes under the EU AI Act when its systems or their output reach the EU.
- In the United Kingdom
- The United Kingdom has no single AI statute, and its regulators apply existing law sector by sector. The EU AI Act still reaches a UK company whose systems or output are used in the EU.
Wherever the company sits, the EU AI Act applies once a system or its output is used in the EU.
For the detail between two particular countries, set your route on the home page. Lexaero does not advise on tax, customs, banking or work permits, and does not broker investments. Where they matter, it says so and works with the adviser you choose.
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