Medical Device News – April 2020 Regulatory Update

In this episode of the Medical Device made Easy Podcast, we will review;

• How Coronavirus is shaking the Medical Device World?
• The Notified Body Situation
• The Anniversary of the Mini-Course MDR 2017/745
• New MDCG guidance released in April 2020
• All the events that happened at Easy Medical Device Check the links section to find all the sources for the information provided.

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

CORONAVIRUS

• LinkedIn Poll 1 year delay: https://www.linkedin.com/posts/melazzouzi_medicaldevices-eumdr-easymedicaldevice-activity-6657212846474092544-vVKi
• Easy Medical Device Pack Template: https://easymedicaldevice.com/shop
• Commission guidance FAQ: https://ec.europa.eu/docsroom/documents/40607/attachments/1/translations/en/renditions/native
• UK MHRA exemption: https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak
• MHRA flexibility: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19
• Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak
• ISO Standards available during Coronavirus: https://www.iso.org/covid19

NOTIFIED BODY SITUATION

• NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main

MINI-COURSE MDR 2017/745

• Course link: https://easymedicaldevice.com/mdr

MDCG GUIDANCE

• MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-5: Guidance on Clinical Evaluation – Equivalence https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-6: Guidance on Sufficient Clinical Evidence for Legacy Devices https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-7: Guidance on PMCF Plan Template https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-8: Guidance on PMCF Evaluation Report Template https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-9: Regulatory requirements for ventilators and related accessories https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-3 rev1: Interpretation of Article 54(2)b https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

PODCAST EPISODES

• Episode 71 – MDR & Drug-Device Combination products with Theresa Jeary https://podcast.easymedicaldevice.com/71/
• Medical Device School: Why are Staff hiding problems to QA RA departments with Karandeep Badwal https://podcast.easymedicaldevice.com/mds11/
• Episode 72 – The 1-year Delay of EU MDR 2017/745 with Erik Vollebregt https://podcast.easymedicaldevice.com/72/
• Episode 73 – Calculate your Sample Size with Jon Bergsteinsson https://podcast.easymedicaldevice.com/73/

LINKEDIN LIVE

• How to certify your class Ir Reusable Surgical Instruments (EU MDR 2017/745) https://youtu.be/-sSo-_V0zbY
• Workshop: How to write your Intended Purpose? [Medical Device case study] https://www.youtube.com/watch?v=t4RaJKC9xeM

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