Archives: Episode

• Medical Device News: December 2021 Regulatory Update

  EUDAMED Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078 EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/ UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf Infographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdf Categorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdf Registration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdf IVDR expert panel View in […]

• Let’s unleash “MDR Classification surprises” [MDR 2017/745]

  Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he […]

• How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]

  One of the most stressful situations in the medical device business is the selection and the work with Notified Bodies. Why? Because there are less than what we need and […]

• Is it possible to Private Label a Medical Device under MDR & IVDR?

  If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or […]

• How to improve your QA RA Communication with Lesley Worthington?

  We always think that what is most important in QA RA is to know the regulation. NO!. What is most important is to be able to transmit this knowledge to […]

• Medical Device News – November 2021 latest update

  In this episode of the Podcast we will review: IVDR proposal to delay transition periods Cobalt on medical devices as CMR Artificial Intelligence MDCG guidance Notified Body overview Check links […]

• How does the EU Commission plan to save IVDR 2017/746?

  A few weeks ago, we were surprised to hear that the EU Commission issued a proposal to delay some products from applying IVDR 2017/746 by my 26th, 2022. So we […]

• How to comply with MDR when products contain CMR Substances?

  In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to you what […]

• EUDAMED Update: Should you register your medical devices now?

  Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to listen to as this may […]

• Medical Device News – October 2021 Regulatory Update

  Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised representative, a Swiss representative or […]