CE/MDR 및 IVDR에서 요구하고 있는 사후 시장 감시 (Post-market Surveillance) 에 대해 안내를 드립니다.

새로운 유럽 의료기기 규정 (Medical Device Regulation) 에서는 의료기기 정기 안전 업데이트 보고서 (Periodic Safety Update Reports, PSUR) 및 사후 시장 감시 보고서 (Post-market Surveillance Reports, PMSR) 를 준비해야 합니다.

PMSR 은 1등급 제품을 대상으로 하며 MDR Chapter VII, Article 85 에 아래와 같이 설명되어 있습니다.

Article 85 Post-market surveillance report

Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and descript-xion of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.

PMS (Post Market Surveillance) 데이터의 결과와 결론을 시장 내 제품에 대해 취한 시정조치의 근거 및 설명과 함께 요약해야 합니다. 이 보고서는 기술문서(TCF, Technical Documentation) 의 일부가 되며 필요에 따라 업데이트가 되고, EU 기관의 요청에 따라 제공될 수 있어야 합니다.

PSUR은 기본적으로 고위험 등급에 대한 내용을 포함한 PMSR의 확장 개념입니다. PSUR은 Class IIa 부터 Class III 및 인체 삽입(Implanted) 제품을 대상으로 하며, PMSR 과 유사하게 PMS 데이터의 결과와 결론을 요약하여 관리하며, 유럽 시장에서의 유사제품의 사후 시장 정보, 부작용 보고 및 현재 상태에 대한 정보를 제공하여야 합니다. 이는 MDR Chapter VII, Article 86 에서 아래와 같이 설명됩니다.

Article 86 Periodic safety update report

1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and descript-xion of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:

(a) the conclusions of the benefit-risk determination;

(b) the main findings of the PMCF; and

(c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.

Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.

For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.

2. For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in Article 92 to the notified body involved in the conformity assessment in accordance with Article 52. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
3. For devices other than those referred to in paragraph 2, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.

위 1항에 따라 PSUR 는 다음을 포함해야 합니다.

• 위험/이익 결정의 결론
• PMCF (Post Market Clincal Follow-up) 의 주요결과
• 장치의 판매량
• 기기를 사용하는 사용자의 기타 특성 (확인되는 경우 사용빈도)의 추정치

모든 제품은 이 보고서가 작성되어야 하며 아래와 같이 구분하여 관리할 수 있습니다.