Medical Device Type Approval Tests

The Medical Device Regulation published by the Ministry of Health imposes a type examination. Accordingly, type examination is the process of testing and documenting the compliance of the manufactured medical device sample with the criteria specified in the regulation in question by the notified body. Documents required for the conformity assessment of the sample introducing the medical device are made in the annex of the regulation while the type approval application is made. The notified body may also request other samples if necessary.

The main documents issued to the notified body must ensure that the design, production and device performance are understood. In addition, a general device definition, including planned changes, should be made. Design drawings, foreseen production methods and especially sterilization subject should be explained in detail and diagrams showing the important parts, accessories and circuits should be given. Likewise, the way the medical device works should be explained.

In the meantime, during the type approval application, a list of the standards applied in whole or in part within the standards in the regulation should be given. If these standards are not applied, solutions that comply with the requirements of this regulation should be explained.

During the type approval application, design calculations, risk analysis, examinations and technical test results should be given to the notified body.

In the light of all these information and documents submitted, the notified body examines and evaluates whether the medical device is manufactured in accordance with these documents and whether the standards contained in the regulation are complied with. If the standards in the regulation are complied with, the necessary measures to assess whether these standards are actually appliedperforms or perform tests and tests. If the standards in the regulation are not complied with, the company conducts the necessary research and tests to verify whether the solutions proposed by the company meet the basic requirements.

At the end of the tests and evaluations carried out, if it is understood that the company complies with the regulation principles, a type approval certificate is issued and delivered to the company.

Medical device type approval tests are also carried out by our organization within the scope of type approval tests.