A gap analysis or Biological Evaluation Plan gives companies the chance to “review all information and . The European Union Medical Device Regulation of 2017. It’s going to cause a cascade of other delays—only some of which can be foreseen. Due to bilateral agreements with the EU, Turkey has a similar status to EFTA countries regarding the MDR and is on course to introduce its own national version of the legislation. On 3 April 2020, NAMSA’s EU Regulatory experts provided a critique of The European Commission’s proposal to delay the date of MDR application by one year, found here.Crucially, there appeared to be a discrepancy between the proposed date of delay and Article 120 section 3, which itself was updated under the second corrigenda to the MDR in late 2019. When: July 22nd 2020, 11.00am – 12.30pm EST Where: Online Event How: Register online now Why: You will learn what the EU-MDR extension means for your organization, and how the extra time should be leveraged for both new and legacy devices. Medical device companies must take a clear-eyed view of what advantages they currently have and then leverage them however possible. The delay gives medical device engineers the chance for a gap analysis and an optimized testing plan, says an expert chemist and toxicologist. As it stands, if the Commission’s proposal is passed, the UK MDR will come into effect prior to the MDR. EU regulators move to delay major MDR changes by one-year amid COVID-19 crisis Calvin Barnett 27th March 2020 EU regulators move to delay major MDR changes by one-year amid COVID-19 crisis 2020-04-24T23:11:51+01:00 Coronavirus News , COVID-19 Sector News , COVID-19 Trade News , Government & Local Authorities , Newsroom , Retailer News , Sector News , Supplier News , Trade News It will take months to get back to pre-Covid-19 levels and so the focus had to be on business safety and continuity. . On Friday, April 17, 2020, the European Parliament voted 693 votes in favor, one against, and two abstentions for the EU MDR delay. With the global COVID-19 pandemic disrupting industries, stakeholders in the medical devices industry have rapidly diverted efforts from the short-term urgency of ensuring regulatory compliance by 26 May 2020, to ensuring the immediate delivery of vital medical devices.. The delay of EU MDR by one year was absolutely critical for the medtech industry to focus on its Covid-19 response. Numerous MDR clauses address transition issues and new regulations that do not involve reporting information to EUDAMED. The MDR delay may not have a major impact on these plans, but it potentially opens up the possibility of aligning individual nations’ implementation dates with the new May 2021 target. Published In: MD+DI. If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you … What This Means For Medical Device Manufacturers. EU MDR Delayed to Prioritize Fight Against COVID-19 Apr 14, 2020 On April 3rd, the European Commission adopted a proposal to delay the application of the EU MDR by one year, to May 26, 2021 in order to allow “Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic.” This whitepaper looks at MIR under the EU MDR. If it is not possible to delay the EU MDR and IVDR deadlines, the U.S. is asking to allow legacy products currently deemed safe to be sold on the market until 2024. It’s also likely a leading indicator of other incoming changes to come. Video Panel Discussion: Update on the EU MDR Delay and Impact on Industry: With confirmation of the EU MDR delay due to COVID-19, MedTech Summit brought together four industry insiders to discuss the … One key change with the MDR that is most impactful in the current landscape of COVID-19 resource scarcity is that the MDR requires all currently approved devices to be recertified. EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.. The UK MDR is due to be effective from 31 December 2020. EU MDR changes are only the beginning – ensure IFU compliance now and be prepared for more to come . Despite the delay of EU MDR into May 2021, some organisations are still burning valuable time in terms of updating the labelling and instructions for use (IFUs) of their medical devices. The EU Medical Device Regulation (MDR, 2017/745) has been underway for years and has hefty implications for medical device manufacturers in Europe as well as for the ecosystem surrounding medical devices including Notified Bodies and Economic Operators involved in the assessment, production, and distribution of medical devices.On April 17, the European Parliament publicly announced a delay … Ultimately, the EU MDR delay isn’t one delay. The delay on the application date of the MDR will avoid potential market disruption and continue supply of medical devices vitally important to manage the unanticipated impact that the COVID 19 outbreak and health crisis have caused on Member States, national authorities, health institutions, EU citizens, and economic operators. The Regulations With less than 2 months to go to the date of application of the EU Medical Devices Regulation 2017/745 (MDR), set for May 26, 2020, the Commission finally announced on March 25, 2020 1 that work is ongoing to postpone this by one year.