Surgical microscopes are medical device products. In the EU, such medical device products must comply with Directive 93/42/EEC. For products that comply with this directive, you can apply for a CE (CONFORMITE EUROPEENNE) certificate through a notary body (Notify Body). Products with a "CE" mark can be freely circulated in EU member states. Medical device products from other countries or regions must also comply with corresponding directives and pass CE certification to enter the EU market.

At present, the EU's new medical device regulations MDR have been implemented in time according to categories. The new MDR is a higher level of EU laws and regulations.

The European Union divides medical devices into four categories for supervision, namely I, IIa, IIb, and III (Class III is the highest and has the strictest supervision). Surgical microscopes belong to Class I regardless of Directive 93/42/EEC or the new MDR regulations.