April 06, 2020

Medical Device News – March 2020 Review (EU MDR)

25 minutes

https://www.youtube.com/embed/XDN1PoDveuQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode of the Podcast, I will provide you with the situation for the month of march 2020 and what should happen next.

As you may know we are in the beginning of a pandemic and this is really a stressful situation for all countries worldwide. So this episode will also show you some elements that should be interesting for you to know during this period.

We will also discuss about the Notified Body Situation. There is a new Notified Body that was announced but this is not enough. We need more. Let’s see the numbers.

I will also list the MDCG guidances and regulatory updates that were released.

Finally, we will review what happened at Easy Medical Device during that month.

Don’t miss the links with all the source of information

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Coronavirus
- DoA delay 1 year: https://audiovisual.ec.europa.eu/en/video/I-187348

Proposal for extension of MDR DoA to + 1 year: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585914772359&uri=COM:2020:144:FIN

Erik Vollebregt Blog Post: https://medicaldeviceslegal.com/2020/04/04/the-mdr-amendment-proposal-more-than-meets-the-eye/

Notified Body audits suspended: https://www.dakks.de/en/content/dakks-adopts-safety-measures-suspension-site-assessments

Coronavirus impact on the Medical Device Industry: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns

MHRA guidance: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19

Free Standards available for Covid19 products: https://www.cencenelec.eu/News/Press_Releases/Pages/PR-2020-003.aspx

Notified Body Situation

State of play March 2020: https://ec.europa.eu/docsroom/documents/40341?locale=en

MDR 2017/745 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

IVDR 2017/746 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

Regulatory Updates

Harmonized Standard update for MDD 2020/437: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235207379&uri=CELEX:32020D0437

Harmonized Standard update for AIMDD 2020/438: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235819491&uri=CELEX:32020D0438

Harmonized Standard update for IVDD 2020/439: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235896183&uri=CELEX:32020D0439

MDCG Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software 2020-1: https://ec.europa.eu/docsroom/documents/40323?locale=en

MDCG Guidance Class Transitional Provision under Article 120(3 and 4) 2020-2: https://ec.europa.eu/docsroom/documents/40324?locale=en

MDCG Guidance Significant Change 2020-3: https://ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native

Easy Medical Device podcasts

Episode 67 – Cybersecurity with Erik Vollebregt: https://podcast.easymedicaldevice.com/67/

Episode 68 – Class Is, Im and Ir with Elem Ayne: https://podcast.easymedicaldevice.com/68/

Episode 69 – Significant Changes with Erik Vollebregt: https://podcast.easymedicaldevice.com/69/

LinkedIn Live

How to classify a Medical Device: How to classify a Medical Device? (EU MDR Case Studies): https://youtu.be/JXuLft-IEZg

FAQ on Economic Operators with Erik Vollebregt: FAQ Medical Device Economic Operators? (EU MDR and IVDR): https://youtu.be/qvOyEofrhgk

Coronavirus outbreak with Erik Vollebregt, Bassil Akra, and Gert Bos: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns

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