30.08.2022
To the attention of all persons interested in the issuance of a waiver from assessment of compliance procedures
On the basis of a justified request, the NAMMDR authorises the placement on the market or commissioning on the territory of Romania of a certain device for which the compliance assessment procedures have not been carried out, but whose use is in the interest of public health or patient health, in line with provisions of Article 59 of Regulation (EU) 2017/745 on medical devices.
This national waiver applies for a limited period (the period considered reasonable for completion of the compliance assessment procedure or the necessity in use of the medical devices subject to national waiver), only in exceptional, well-justified cases, when there is no similar product on the market, when the manufacturer demonstrates that he has started the compliance assessment procedures or, as the case may be, that he has been prevented from completing/initiating these procedures by exceptional and unforeseeable circumstances.
In order to obtain the waiver, the applicant submits to the NAMMDR an application accompanied by documents justifying the fact that the product is safe to use (declaration of compliance issued by the manufacturer, certificate of compliance issued by a notified body (as applicable), technical specification, label, instructions for use, evidence regarding the lack of complaints/incidents, evidence regarding the steps taken in view of certification, other certificates/approvals/authorisations obtained) as well as evidence regarding the need for the respective medical device on the market (lack of a substitute and the need to cover the respective segment).
To solve the request, the NAMMDR may additionally request documents provided for in the legislation applicable to the type of medical device.