欧盟委员会（EC）对欧盟医疗器械法规（REGULATION (EU) 2017/745，简称“MDR”）和欧盟体外诊断医疗器械法规（REGULATION (EU) 2017/746，简称“IVDR”）的滚动实施计划进行了更新，并交代了部分举措所取得的进展。
EC Updates EU MDR/IVDR Implementation Rolling Plan
The European Commission (EC) updated the rolling implementation plan for the EU’s medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), noting progress with certain initiatives.
The rolling plan points to fact sheets published in January. These were addressed to authorized representatives, importers, distributors, authorities in non-EU/EEA states and those involved in the procurement ecosystem for medical devices and IVDs, which include hospitals and clinics. The deliverables were developed as part of the plan’s communication campaign intended to “avoid bottle necks” and ensure medical device access.
In addition to the string of new fact sheets, EC also posted infographics and 2020/2022 transition timelines last month to aid in preparations for the increased regulatory requirements.
The Medical Device Coordination Group (MDCG), which was established in 2017 to help guide the direction of the essential implementing acts and actions outlined and routinely updated in the MDR/IVDR rolling plan, issued a set of new guidance documents as well. These two guidance documents, which EC posted in January and February, cover certificates and voluntary certificate transfers and the application of unique device identification (UDI) rules specific to the device part of the medical product. MDCG guiding principles for issuing entities on the Basic UDI-DI [direct marking] requirements were posted last month.
The survey with MDCG members is now marked as finalized in the areas for which results would support future drafts of the identified implementing acts. These include those pertaining to expert panels, including fees, EU reference laboratories and expert laboratories and details around Eudamed. At the time of its October 2018 release, the rolling plan had marked the survey as ongoing through the relevant implementing acts.
The consultation of MS and Cen/Cenetec on the scope of the standardization mandate is now complete.
The implementing act on common specifications for products without a medical purpose has been delayed. It was originally set for Q3 2018, then delayed to the beginning of 2019 and now to Q1 2020.
The rolling plan remains subject to quarterly reviews for updates throughout the MDR/IVDR transitions.