4월 17일, European Parliament(유럽 의회)가 Medical Devices Regulation (MDR) 2017/745 적용시점(Date of Application)을 1년 뒤로 연기하는 European Commission(유럽 위원회)의 제안을 채택 했습니다. 지난 3월 25 일 유럽위원회는 COVID-19 Pandemic으로 인한 예외적인 상황이 MDR 이행에 영향을 미칠 것으로 판단하여, MDR 적용을 지연시키기 위한 긴급 제안을 마련하였습니다.

이로써, 2020년 5월 26일로 예정되어있던 MDR 적용시점은 1년 뒤(2021년 5월 26일)로 연기 되었으나, 2024년 5월 27일부터는 MDD/AIMDD 인증서가 무효화 되고 2025년 5월 27일 이후에는 CE MDD 인증서로 제품 신규 판매나 사용이 금지됩니다. 그 이후 타임라인은 변경되지 않습니다. 또한, IVDR (In Vitro Diagnostics Regulation) 에 대한 적용 시점 연기 계획은 아직 없는 것으로 보입니다.

MDR Date of Application delay confirmed

On Friday 17 April 2020, the European Parliament adopted the European Commission’s proposal to postpone the implementation of the Medical Devices Regulation (MDR) 2017/745 by 12 months. This urgently drafted proposal to delay the MDR is in response to the exceptional circumstances associated with the COVID-19 pandemic and the potential impact it may have had on the MDR implementation.

The proposal now also has to be approved by the member states and published in the Official Journal of the European Union (OJEU) before it enters into force. This is expected to be by 26 May 2020 at the latest. Once in force, the new Date of Application (DoA) for the MDR will be 26 May 2021.

Without a doubt, this one-year delay will bring some welcome relief from the intense pressure on organizations, notified bodies and competent authorities to complete the MDD/AIMDD transitions and early renewals before the 26 May 2020. However, despite the postponement of the DoA, we will continue to employ our resources on critical devices in the context of the COVID-19 pandemic and conformity assessments under the MDR to ensure effective implementation of Regulation.

It is important to note that, although the DoA has been delayed by one year, the key deadline of 26 May 2024 when the Directive based certificates issued by notified bodies become invalid remains the same. We would strongly recommend that, to ensure timely certification, you work towards the original dates in your strategic regulatory plans.

We are not aware of any current plans to delay the DoA of the In Vitro Diagnostics Regulation (IVDR).

There is still a mountain to climb to ensure all products transition to the MDR in a timely fashion, so we recommend you maintain your current focus.
 
We would like to thank you all for your efforts over the last few years, and the patience you have shown through what are unprecedented times.

We hope you and your families are safe and well.

With best wishes,

자세한 내용은 아래 링크를 통해 확인하실 수 있습니다.

European Parliament(유럽 의회)

MDR 신청 날짜를 2021 년 5 월 26 일로 수정하는 개정 규정 2020/561이 EU 공식 저널에 게재되었습니다. 상세 내용은 아래 링크를 참고해 주세요.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020R0561