MDR technical documentation assessmentt

Assessment of the MDR Technical Documentation within the MDR conformity assessment procedure

의료기기 EU 시장 접근을 달성하는 방법

의료기기 EU 시장 접근을 달성하는 방법

ASSESSMENT OF THE MDR TECHNICAL DOCUMENTATION WITHIN THE MDR CONFORMITY ASSESSMENT PROCEDURE

For products that are classified as Class II/III medical devices the Medical Device Regulation (MDR) requires an assessment of the technical documentation within the scope of the MDR conformity assessment procedure to place devices on the EU market.

To bring medical devices into the EU market, depending on the classification and chosen MDR conformity assessment procedure the legal manufacturer may need an additional EU technical documentation assessment certificate besides his EU quality management or quality assurance system certificate.

In the case of initial product certification the process starts with a combined pre- application and application phase to ascertain that a product can be certified from a regulatory point of view.

In the case of modification of a certified product the process starts directly with the change related application phase.

The next step in both processes is the assessment of the MDR technical documentation. A positive result of the review and the independent certification decision enables the issuance of the related certificate.

 

Pre-Application Phase

You have a new medical device (initial certification)

Please start with the Pre-Application Phase

Pre-Application Phase

Application Phase

You have changes on a certified medical device (change notification)

Please start with the Application Phase

Application Phase

New Medical Device Regulation
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유럽 의료기기규정 MDR (Medical Device Regulation) 인포그래픽

2017년 5월 5일 유럽 위원회는 의료 기기에 대한 새로운 규정을 발표했습니다.

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Mhs technical document

TÜV SÜD Technical Documentation

According to the Medical Device Regulation (EU) 2017/745 (MDR)

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medical devices

MDR 문의하기

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