Our March MedTech news covers MDR updates from Europe & the UK, an insightful piece on leveraging real-world evidence in regulatory submissions, useful resources recently published by the FDA, the latest from Asia-Pacific and information about two free online FDA workshops coming up in April.
MDR updates from Europe and the UK
The Medical Device Coordination Group (MDCG) has endorsed a document covering Questions and Answers on Custom-Made Devices (including consideration of Adaptable and Patient-matched medical devices). The high-level document is aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017 / 745 on medical devices (MDR). Click here to access the document.
On March 5, the MHRA published a new version of their guidance document for placing devices on the Northern Ireland market. This version now clearly references MDR and IVDR regarding importers, distributors and manufacturers, with the below requirements taking effect from May 26, 2021 for medical devices, and May 26, 2022 for IVD’s:
- The importer must comply with Article 13
- Distributors must comply with Article 14
- Manufacturers or their AR must comply with Article 15 about the Person Responsible for Regulatory Compliance
Find out more here.
Leveraging real-world evidence (RWE) in regulatory submissions
Advances in the availability of real-world data (RWD) sources have increased the potential to generate robust real-world evidence (RWE) to support FDA regulatory decisions. Jeff Shuren and Daniel Caños from the CDRH discuss leveraging RWE in regulatory submissions for medical devices in this recent article.
Useful resources from FDA
FDA has made available a comprehensive set of coding resources for use when selecting event codes for a Medical Device Report. Information about the codes, and the MedWatch Medical Device Reporting Code Instructions (sometimes referred to as the coding manual) is also included. Read more here.
Looking for information on biocompatibility? See here for FDA’s recently published resources that explain the important terms and concepts regarding the evaluation of biocompatibility of medical devices.
Terms like “FDA Registered”, “FDA Certified” or “FDA Registration Certificate” often appear on websites selling medical devices in the US. But none of these terms mean the same as “FDA approved”, “FDA cleared” or “FDA authorised”. This article by the FDA provides important clarity on how to determine whether a medical device is authentically FDA approved.
The latest from Asia-Pacific
Australia’s TGA has issued the Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021, which amends the Therapeutic Goods Act 1989. This new regulatory amendment stipulates that the TGA will develop its own UDI database for medical devices, to be known as the Australian Unique Device Identification Database. Find out more here.
In China, the NMPA has released the Annual Report for Medical Device Registration. Despite the impact of the pandemic, the total number of medical device acceptances in 2020 increased by 15.6% compared with 2019. Last year also saw Switzerland make it into the top five countries for the initial registration of imported medical devices into China. Find out more here.
Free FDA workshops – Consensus Standards and ASCA Pilot
On April 13, FDA will be holding two online workshops for those involved in the medical industry, testing laboratories or accreditation bodies. “How to use Consensus Standards in Premarket Submissions” will run from 1pm – 2pm ET, and “The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions” will run from 2pm – 3pm ET. There is no fee to attend, registration is not required, and participants can attend one or both of the workshops. Find out more here.
That concludes our March MedTech news. Check back in April for more updates.
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