EU Medical Device Regulation MDR 유럽의료기기 규제 개정

EU Medical Device Regulation

Significant changes ahead for medical device manufacturers

Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). A new medical device regulation (MDR) is making its way through final tri-party negotiations between the EU Commission, the European Council and the European Parliament. Once final approval is achieved, the MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

The proposed MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the proposed regulation include:

Key changes 

•  Product scope expansion - The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that may not have a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also expected to be included in the scope of the regulation are devices designed for the purpose of “prediction” of a disease or other health condition.
•  More stringent clinical evidence - The MDR will require device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with the risk associated with a given device. Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
•  Identification of “qualified person” - Device manufacturers will be required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new MDR. The organisation must document the specific qualifications of this individual relative to the required tasks.
•  Implementation of unique device identification - The proposed MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.
• Rigorous post-market oversight - The MDR will grant Notified Bodies increased post-market surveillance authority. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers will also be required in many cases.
•  Specifications - The MDR plans to allow the EU Commission or expert panels to be defined to publish Common Specifications which shall then be taken into account by manufacturers as well as Notified Bodies. These Common Specifications shall exist in parallel to the Harmonized Standards and the State of the Art.

Time line 

At present, the final approval of the MDR is expected sometime in 2016, but this timeframe is dependent upon the successful conclusion of consultations between the EU Commission, the EU Parliament and the EU Council. Once approved, it is expected that manufacturers of currently approved medical devices will have a transition time of three years from publication to meet the requirements of the MDR.

It is important to note that, as an EU regulation, the MDR will have the force of law throughout the EU when it comes into effect. While this will eliminate country-by-country interpretations of the requirements permitted under current directives, it might also speed up the implementation of the MDR’s requirements across the EU.

How to prepare?  

Additional changes to the MDR are still possible at this stage of the legislative procedure, and the actual terms of the proposed regulation are not final until the publication of the MDR in the Official Journal of the European Union. However, the complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time consuming process for most device manufacturers. Further, currently approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.

Medical device manufacturers are well-advised to stay current on the progress of the MDR through the legislative process, as well as additional changes that may impact them. In addition, since a large number of medical devices will now require Notified Body review and approval, delays in the review and approval process by Notified Body should be expected. Therefore, it is recommended that manufacturers of currently approved devices consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.

연합뉴스 발췌

개발, 승인, 시판과 사용 이후 단계에 이르기까지 안전과 품질 관련 검사, 감독, 윤리규정 등을 촘촘하게 강화하는 데에도 초점이 맞춰져 있다.

우선 의약품처럼 의료기기도 효과와 안전성이 확인된 임상시험 결과를 꼭 첨부해야 하는 등 제품 승인이 더 까다로워진다.

유방보형물이나 인공고관절, 에이즈바이러스 진단 검사 등 '고위험 기기'의 경우 별도의 추가 안전검사를 거쳐야 하며 인증기관 뿐 아니라 전문가 특위의 심사까지 받아야 한다.

인증기관도 반드시 일정 수준의 '의학적 훈련을 받은' 인력을 일정 규모 이상 고용해야 하는 등 인증기관의 기준과 운영, 감독도 강화된다.

또 제품 출시 이후에도 반드시 제조업체와 공장을 무작위로 선정해 불시 방문, 실사해야 한다.

특히 주목되는 것은 보형물 등 임플란트 제품마다 제조회사와 연도, 제품 일련번호, 특성 등의 각종 정보를 데이터베이스(DB)에 등록하고 당국뿐만 아니라 환자와 의사도 인터넷으로 간편하게 찾아볼 수 있도록 한 '개별 기기 신원확인'(UDI) 제도의 도입이다.

수술받은 환자는 모두 일명 '임플란트 카드'를 받게 되며 만약 문제가 발생할 경우 이를 이용해 DB에 접속, 자신이 결함 있는 제품을 이식받았는지 등을 신속하게 확인할 수 있다.

프랑스 업체 PIP가 공업용 실리콘으로 만든 유방 성형 보형물을 제작 판매했음이 2012년 드러났다. 이로 인해 수십명이 유방암에 걸렸으며, 이를 이식받은전세계 수십만명의 여성이 불안에 떨고 이 가운데 수만명 이상이 제거수술을 받는 일이 벌어졌다. 사진은 2012년 10월 프랑스 남부 니스의 병원에서 의사가 문제의 유방 성형보형물을 제거한 뒤 들고 있는 모습(EPA=연합뉴스 자료사진)

 

개정안은 인공고관절 부작용 등 의료기기 안전 사건이 잇따르면서 기존 법규에 허점이 많다는 지적에 따라 마련된 것이다. 지난 2012년 프랑스 업체가 공업용 실리콘으로 만든 발암성 유방 성형 보형물로 수십명이 암에 걸리고 이를 이식받은 수십만명이 불안에 떨었던 사태가 발생하기도 했다.