Surgical microscopes are classified as medical devices. In the European Union, such medical devices must comply with Directive 93/42/EEC. For products in line with this directive, you can notary public (Notify Body) for CE (CONFORMITE EUROPEENNE) certificate application, the product affixed with the "CE" mark can be in the EU members of the free flow of domestic. Other countries or regions of the medical device products to enter the EU market also need to comply with the corresponding directives and through the CE certification.
Currently, the new MDR has been implemented according to the categories of medical devices. The new MDR is a higher level of EU legislation.
The EU regulates medical devices in 4 categories, i.e. I, IIa, IIb, III (III is the highest and most strictly regulated). Surgical microscopes belong to Class I, whether according to Directive 93/42/EEC or the new MDR regulation.