17 Feb The European Commission is preparing new documents to assist medical device manufacturers in adapting to the MDR.
The new regulation on medical devices is almost upon us. In May 2021 the Medical Device Regulation 745/2017 will enter into force. In order to facilitate the implementation process for medical device manufacturers, the European Commission has produced various documents on the different aspects covered by the new regulation.
The process goes through expert groups involving Member States’ competent authorities, as well as industry associations and Notified Bodies. Upon completion of these documents, they are submitted to the Medical Device Coordination Group (MDCG) for approval and adoption.
In the last quarter of 2020, several documents have been released.
MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
This guidance relates directly to Article 27 of the Medical Device Regulation (EU) 2017/745 (MDR). This article introduces a Unique Device Identification (UDI). The UDI aims to improve the identification of devices and to improve the effectiveness of post-market safety-related activities for devices. The guide clarifies the UDI allocation obligations for manufacturers of spectacle lenses and pre-mounted spectacles. This guide takes into account their specific characteristics. Product characteristics are listed at the UDI-basic and UDI-DI level that allow the categorisation or grouping of products.
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
In this case, the guidance provides clarification on the classification rules for in vitro diagnostic medical devices. This guide also applies to information society services or diagnostics performed on patients in the European Union. It also applies to devices put into service through distance selling. This document is intended to provide guidance to manufacturers of in vitro medical devices, notified bodies and health institutions on how to classify these devices. It also provides guidance for classifying the risk level of in vitro diagnostic medical devices.
If you are a medical device manufacturer and you need to know what level of risk applies to your medical device, EpisKey Medical Consulting can help you with all these questions.