Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and …

2020年8月27日 · This document declares in substance the devices have been developed, designed and manufactured in compliance with the appropriate conformity assessment requirements dictated in the MDR or IVDR. As under the MDD and the IVDD, CE marked medical devices must be supplied with an EU DoC under the MDR and the IVDR.

As a general requirement, the manufacturer of medical device or accessory in compliance with the applicable requirements of MDR 2017/745 must declare the conformity with an EU DoC (Article 19 in combination with Annex IV of MDR 2017/745). The medical devices and accessories must be covered with a single Basic UDI.

2023年12月13日 · EU DoC (Declaration of Conformity) 一般中文稱為「歐盟符合性聲明」，是由製造商發布的正式文件，用來聲明產品已符合MDR或IVDR及相關安全法規要求，透過發布及簽署DoC，製造商也承擔維持產品合規性的法律責任。

MDR DOC is a document in which the manufacturer declares that the medical device/in-vitro diagnostic device complies with the requirements of MDR/IVDR and all the Union legislation applicable to the device. The DOC needs to be continuously updated by the manufacturer.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Official Journal).

On 26 May 2017, a new regulation entered into force, meaning that by 26 May 2020, for manufacturers to obtain or renew a CE certificate or to issue a Declaration of Conformity (DoC), their technical documentation will need to comply with the Medical Device Regulation (MDR) European Union (EU) Regulation 2017/745 (referred to as ‘MDR ...

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR.

Update of MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746.

Here is the direct link to MDR English version HTML with TOC Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.