The transition to the new EU MDR and IVDR regulations was a major focus in 2019, with concerns around limited guidance and the looming May 2020 implementation deadline. The US requested a three-year delay due to inadequate notified bodies and guidance. However, the EU commissioner has not changed the deadline. Brexit was also a major issue, with UK notified bodies set to lose accreditation and manufacturers needing to transfer certificates and authorized representatives to EU entities. Looking ahead to 2020, the FDA will finalize rules around ISO 13485 harmonization and digital health pathways.

1. 2019 at a Glance and What's Coming in 2020
By: Nikita Angane, MS
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.i 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. ii
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. iii
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

2. Page 2 of 2
medical device manufacturers, of which 24 were for domestic manufacturers and 2 international
firms.iv
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.
i World 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&Ful lTextHash=371857150&HasEnglish
Record=True&HasFrenchRecord=True&HasSpanishRecord=True
ii RAPS (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
iii RAPS (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
iv FDA: ComplianceActions retrieved on 12/31/2019 from
https://datadashboard.fda.gov/ora/cd/complianceactions.htm