The European Union’s Medical Device Regulation (MDR) 2017/745 establishes a comprehensive framework for the clinical evaluation of medical devices, ensuring their safety and performance before market introduction. Central to this framework is the categorization of clinical investigations, each serving distinct purposes in the device development lifecycle. The primary types of clinical investigations include Exploratory, Observational, …
On July 09 2024, Regulation (EU) No 2024/1860 has been published. This Regulation introduces the following key changes:– a gradual roll-out of Eudamed,-the obligation to inform in case of interruption or discontinuation of supply,-transitional provisions for certain in vitro diagnostic medical devices Only IVDD legacy devices may benefit from the extended transition period if: The …
European Commission issued a proposal 2024/0021 (COD) for amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain IVDR. Once approved by the council and parliament this will give more time for many IVD manufacturers to comply …
The change journey of the EU medical device directives since 2012 was completed on 5 May 2017 with the publication of EU 2017/745 and EU/2017/746 in the EU official journal. EU 2017/746, which we are accustomed to briefly refer to as IVDR, entered into force on 26 May 2022. However, due to the COVID 19 …
Many medical device’s manufacturers have difficulties in locating a notified body for CE Marking of their products. This article provides detailed information on the notified body selection criteria which could be implemented by manufacturers who are planning to put their medical devices on the EU market. Still with 30 NBs for MDR and 12 NBs …
We all know that Risk Management is an important part of a medical device’s quality management system. It also plays an important role in establishing objective evidence for the conformity with the General Safety and Performance Requirements (GSPR) of the EU 2017/746 (IVDR) IVD Medical Device Regulation. When carrying out a risk assessment, the state-of-the-art …
Performance evaluation (PE) is an important part of design validation and technical documentation required to place an in vitro diagnostic device (IVD) on the EU market. Article 56 of the EU 2017/746 In Vitro Diagnostics Regulation (IVDR) requires manufacturers to prepare a performance evaluation report to demonstrate the safety and performance according to the manufacturer’s …
Proposal for transitional provisions for certain invitro diagnostic medical devices under Regulation (EU) 2017/746 European Commission issued a proposal (2021/0323 (COD)) for the amendment of the transitional provisions under EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). Once approved by the council and parliament this will give more time for many IVD manufacturers …
The EU Commission has issued guidance documents for Medical Device Software within the scope the EU 2017/745 MDR and EU 2017/746 IVDR. The first publishment related with MDSW is MDCG 2019-11, contains information on the qualification and classification of medical device software. The second one is MDCG 2019-16 which is a guidance document on Cybersecurity for …