The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to create within the industry. With a limited number of guidance documents to guide the device makers, companies are falling behind on the implementation deadline, which is soon approaching in May 2020. US delegates requested delaying the implementation of the MDR and IVDR by three years.1 The US is worried about the 20billion USD market access that US manufacturers will have to lose since 1. there is not an adequate number of notified bodies accredited to the MDR & 2. due to the lack of guidance available for the industry. The US also asked for products that require testing to be done for the first time be given priority access to testing and CE certification by the notified bodies. However, the EU commissioner has declared that the deadline will not be changed. 2
Meanwhile, a second corrigendum which is in the process of being finalized will allow for an extended transitional period for devices which were class I under the MDD and now have been up-classified under the EU-MDR and require the involvement of an NB. You can read more about this new corrigendum here: EXTENDED TRANSITIONAL PERIOD FOR CLASS I DEVICES.
The number of MDR accredited NBs is also a concern for the industry. The roll-out of accreditation has been slower than planned. Only 8 notified bodies have been accredited so far under the EU MDR and two for the EU IVDR. 3
Brexit is another item that tops the list this year. The exit date was pushed a couple of times in 2019 and is now set for the end of January 2020. The MHRA released several guidance documents to guide the industry on the regulations they must follow in order to ensure a continued supply of devices and medicine to the public and avoid any shortages; however, the chaos continues. EU MDR is not the only topic that involves concern about Notified bodies. Under Brexit, notified bodies in the UK will soon lose their accreditation to assess the conformity to the EU regulations. Device manufacturers who currently have their certificates issued from a UK based notified body will no longer be valid after the Brexit. Manufacturers must start the process of transferring their certificates to an EU based NB. The same applies to authorized representatives. Device manufacturers will have to move their ARs from the UK to the EU since a UK based authorized representative will no longer be valid.
On the FDA front, during the past fiscal year (Oct 2018-Sept 2019) FDA conducted 2542 inspections (between foreign and domestic inspections). FDA issued 26 warning letters to medical device manufacturers, of which 24 were for domestic manufacturers and 2 international firms.4
In the spring of 2020, FDA expects to finalize the rule on harmonizing 21CFR820 with ISO 13485:2016, which got pushed back from FDA’s Fall 2019 agenda. Digital Health was a top priority for the FDA this year and will continue to be for the next year as well. Final rules around regulatory pathways for artificial intelligence and machine learning-based devices are expected to come around in 2020.
EMMA International will keep you updated on these changing regulations and can help you implement all required changes in a successful and efficient manner. Give us a call today at 248-987-4497 or email us at info@emmainternational.com to learn more about our CLIC.
1World Trade Organization (2019) STATEMENT BY THE UNITED STATES TO THE COMMITTEE ON TECHNICAL BARRIERS TO TRADE
20 AND 21 JUNE 2019 retrieved on 12/31/2019 from https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009-DP.aspx?language=E&CatalogueIdList=255848&CurrentCatalogueIdIndex=0&FullTextHash=371857150&HasEnglishRecord=True&HasFrenchRecord=True&HasSpanishRecord=True
2RAPS (Dec 2019) 2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020 retrieved on 12/31/2019 from https://www.raps.org/news-and-articles/news-articles/2019/12/2019-in-review-all-eyes-on-mdrivdr-prv-records
3RAPS (Dec 2019) Number 8: Dekra’s Dutch NB Designated Under MDR retrieved on 12/31/2019 from https://www.raps.org/news-and-articles/news-articles/2019/12/number-8-dekras-dutch-nb-designated-under-mdr
4FDA: Compliance Actions retrieved on 12/31/2019 from https://datadashboard.fda.gov/ora/cd/complianceactions.htm
