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Parliamentary questions
PDF 103kWORD 18k
18 July 2018
Question for written answer E-004020-18
to the Commission
Rule 130
Paul Rübig (PPE)

 Subject:  Introduction of EU medical standards for opthalmology
 Answer in writing 

Opthalmologists are required to observe various standards in the course of their day-to-day work. Some of these are enshrined in agreements whereby professionals undertake to adhere to the ‘laws’ of the art of medicine. Rules of this type govern the opthalmologist’s relationship with patients. When it comes to determining a patient’s powers of vision, there are standards laid down, for example, by the International Council of Ophthalmology (ICO). On the other hand, there are EN ISO (European and International Organisation for Standardisation) industrial standards both for the manufacture of eye-testing equipment and for the conduct of eye tests and the drafting of opthalmologists’ reports.

In certain cases, however, the EN ISO and the ICO standards do not match. This can lead to situations in which types of eye test that meet the ICO standard but not the EN ISO standard cannot be marketed in the EU.

What is the Commission’s view as to the possible introduction of EU-level medical standards in the field of opthalmology?

Original language of question: DE 
Last updated: 2 August 2018Legal notice