Three-quarters of medical device companies are ready to meet EU MDR and IVDR regulations
A research report from RWS, a provider of technology-enabled language, content management and intellectual property services, has painted an optimistic picture about the readiness of medical device manufacturers to meet the European Union’s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) deadlines.
First published by the EU Parliament in 2017, the European Union’s (EU) Medical Device Regulation and In Vitro Diagnostic Regulation set standards and oversight requirements for manufacturers of medical devices and in vitro diagnostic solutions that intend to distribute their products in the EU.
The research by RWS involved leading medical device organisations operating in Europe and looked at how the pandemic has affected their preparations to meet the 26 May 2021 deadline for the EU MDR – which had been delayed by one year – and the EU IVDR deadline of 26 May 2022.
Its research highlighted how 44 per cent of organisations admit the MDR and IVDR regulations are their top priority. It found that almost three-quarters of organisations were positive about meeting the MDR deadline, while 69 per cent remain positive about meeting the IVDR deadline in 2022.
Meanwhile, 42 per cent said that technology stack evolution is the most important transformation initiative they have put in place to complete EU MDR/EU IVDR compliance, and 56 per cent of organisations felt that COVID-19 had a “significant” impact on supply chain management.
The COVID-19 pandemic had the most impact on strategic planning for 2021, according to 45 per cent of respondents. When asked what specific challenges the respondents faced during the pandemic, 50 per cent said increased or decreased product manufacturing demand had the most impact on their business.
Jon Hart, President of RWS Regulated Industries said: “While it’s a positive sign that organizations feel optimistic about meeting their MDR and IVDR commitments, there’s clearly a lot of work to do post-pandemic.
“The decisions that medical manufacturing organisations make now won’t just affect their ability to comply with these two regulations, they will also play a continuing role in how quickly and effectively they can meet compliance standards in years to come.
“Introducing automation into the content management and translation process is a good first step, but a more visionary end-to-end solution that spans the manufacturing organization and the supply chain will better prepare organizations for the inevitable introduction of future regulations.”
The RWS research report, EU MDR & IVDR and Their Impact on the Medical Device Industry, can be downloaded now from its website.
The spectre of EU MDR has been looming large over the medical device industry in what is set to be a continuous flow of new regulations coming down the pipeline for different types of medical devices in the coming years.https://thiis.co.uk/three-quarters-of-medical-device-companies-are-ready-to-meet-eu-mdr-and-ivdr-regulations/https://i1.wp.com/thiis.co.uk/wp-content/uploads/2019/09/walking-frame-e1620650383821.jpg?fit=900%2C601&ssl=1https://i1.wp.com/thiis.co.uk/wp-content/uploads/2019/09/walking-frame-e1620650383821.jpg?resize=150%2C150&ssl=1NewsroomReports & ResearchSector Newscovid,EU MDR,medical device,regulation,RWSA research report from RWS, a provider of technology-enabled language, content management and intellectual property services, has painted an optimistic picture about the readiness of medical device manufacturers to meet the European Union’s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) deadlines. First published by the EU...Liane McIvorLiane McIvorliane@thiis.co.ukAdministratorTHIIS Magazine