What you need to know to submit Study Data to FDA
For those of us in the Medical Device world, this month has been on our radar for a number of years as the long anticipated Medical Device Regulation (EU) 2017/745 (MDR) was due to become fully applicable. However, this has all changed since the Regulation 2020/561 amending the MDR was adopted on the 23rd April 2020. This amendment delays the date of application of the MDR by 12 months due to the current Covid-19 pandemic (https://ec.europa.eu/commission/presscorner/detail/en/IP_20_718). This has come as a relief to a number of device manufacturers who were struggling to ensure their device documentation was compliant with the requirements of the MDR and had issues securing Notified Body QMS audit slots or Technical Documentation reviews.
It is important to note that whilst this postponement does give device manufacturers an extra year for application of the MDR, none of the other timelines have been amended. UDI labelling timelines have not changed, so full compliance for class III and implantable devices is required by 2021, with direct marking of any reusable products in those classes by 2023. Additionally, the previously agreed delay for Eudamed has not been moved, so full implementation is required by 2022. It is; therefore, strongly advised that device manufacturers continue full steam ahead with their activities for MDR compliance.
For those manufacturers who would like to join the fight against the global Covid-19 pandemic, the European Commission has made a number of resources available on their website including guidance regarding introducing PPE, hydro-alcohol gel and conformity assessment procedures for 3-D printing and 3-D printed products: https://ec.europa.eu/growth/content/coronavirus-commission-issues-questions-and-answers-help-increase-production-safe-medical_en
Notified Bodies have also made several applicable standards available for free on their websites, and Competent Authorities have also provided some local guidance to support the effort.
Whether you need guidance to ensure compliance with the MDR or support preparing technical documentation to a tight deadline to support the efforts to tackle Covid-19, the PharmaLex team can support your organisation, please connect with us contact@pharmalex.com
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