Romania: New regulations in the field of medical devices

New implementation rules on approval of activities in the field of medical devices

Starting with April this year, new regulations were adopted regarding medical devices.

According to these rules, trade and service activities in the field of medical devices requiring approval control are as follows:

a) import of medical devices, b) distribution of medical devices, c) installation and / or maintenance of medical devices.

As for the requirements that an economic operator must meet in order to obtain an operating permit, the implementation rules require it to cumulatively meet the following requirements:

· hold an appropriate location, which must be used exclusively for carrying out the activity required for approval,

· be equipped with adequate equipment to carry out the activity required for approval and

· to have sufficient and qualified / trained personnel for the activity it carries out / the field in which it operates.

In addition, an economic operator must have at its disposal, within its own organization, the services of at least one person responsible for compliance with specific regulations in the field of medical devices, and who has the necessary expertise to do so.

‘Necessary expertise’ is proved by a set of documents expressly regulated by the implementation rules.

Another important aspect concerns the validity of operating permits. According to the implementation rules, permits will be valid for three (3) years from the date of issuance (no longer valid for an indefinite period). The deadline for communicating changes to the Romanian National Agency for Medicines and Medical Devices (ANMDMR) remains, namely thirty (30) days from the date the change occurred.

According to the normative act, operating permits issued until the date of entry into force of the implementation rules remain valid for two (2) years and six (6) months from the date of issue or three (3) years from the date of issue, if a renewal request has been lodged.

Another novelty: in the event of declaration of a state of emergency, issuance of temporary operating permits with a validity of six (6) months is now possible.

In addition, the normative act also provides certain conditions regarding personnel with attributions in installation and / or maintenance of medical devices, a procedure for assessment of the file by ANMDMR, a procedure for renewing the operating permit, etc.

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