CONSULTANCY for EU Regulations:

CE Marking and Technical Documentation

CE marking is required to be sold in the EU and Turkey market of medical devices. The EU Commission classifies medical devices as class I, class IIa, class IIb and class III. This classification has sub-categories within itself.

For Class I (non-sterile and non-measuring and non-surgical hand tools) products, registration can be made after the technical documentation in accordance with the requirements of the legislation, without any conformity assessment. Technical documentation includes pre-clinical evaluations and clinical evaluations of the product. Post-sales clinical follow-up study is not mandatory for Class I products.

Class I products, class IIa, class IIb and some class III products, excluding the above, are subjected by notified bodies in this field according to the conformity assessment routes in the legislation, after the technical documentation in accordance with the legislation and the establishment of the quality management system. For this, technical documentation is prepared to be submitted to the notified body according to 93/42 / EC Medical Device Regulation or 2017/745 Medical Device Regulation. Technical documentation includes pre-clinical evaluations and clinical evaluations of the product. Aftermarket clinical follow-up study is mandatory for non-Class I products. In particular, class 2b can be embedded in the body, and a clinical trial or a well-planned aftermarket clinical follow-up study on class 3 products is critical to the transition to the 2017/745 Medical Device Regulation.

The calendar for CE marking processes may vary depending on the product class and notified body evaluation procedures. CE compliance certificates of CE certificate approved by the company in conjunction with medical devices Turkey and EU member states to continue with the registration process and after completion of the registration process becomes possible product sales in the country of registration.

For detailed information, you can contact +90 532 397 3043 or mformeci@gmail.com.

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TRAINING

ISO 13485:2016
CE Marking
510(k) Fundamentals

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TESTING

Biomechanical Testing
Finite Element Analyze