The Agreement on the EEU determines the common market of medical devices. By January 1, 2018, common market of medical devices will come into a force.
New rules draft for registration and expertise in EEU do not imply a uniform registration throughout the EEU “by default”. New rule introduces the concept of “referent country”, a country in which it is assumed the full cycle of medical device registration occurs with the expertise phase and the “recognition countries”, that accepts the results of expertise by the simplified acceptance procedure in short terms. According to the registration rules, a “referent country” and “recognition countries” are selected by the applicant at the beginning of the registration procedure.
The non-acceptance of the expert conclusion of the referent country (see Clause 35) by another country of EEU, according to the draft, could be reason for prohibition medical device circulation in the individual states territory of the EEU.
On 10 August 2016, eleven of the thirteen final editions of second-level documents were published.
| EAC MED- Mark of conformity
| EAC MED – Regulation
regulation by link below
| EAC MED – list of applied standards
Roszdravnadzor news about Recommendation #17 by link – with full text in English and in Russian
What does this mean for manufacturers and testing labs? – analytics by link.
Review for applied standards for different product types: