Hardware Podcasts

099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson

Let's Combinate · 23 Aug 2023 · 40m

What this episode covers

Janine Jamieson, European Editor at International Pharmaceutical Quality, explains the regulatory complexities of drug-device combination products in the EU, detailing her tenure as a pharmaceutical assessor at the UK MHRA. She describes the historical challenges of reviewing device-led products without clear pathways, which led to the introduction of Article 117 in the EU MDR to balance device and medicinal product reviews. The conversation covers the current state of notified bodies, the upcoming New Falsified Medicines Directive (New FMD), and the revision of ICH Q6 specifications to decouple safety from manufacturing capability.

Most relevant to

established companies

Topics

Mentioned

Companies
MHRA, EMA, BSI, LRQA, International Pharmaceutical Quality, TOPRA
Also
EU MDR, ICH Q6

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 24m

    Assessing the Global Regulatory Landscape

    Adnan Ashfaq, founder of Simplimedica, discusses the rocky transition to the EU Medical Device Regulation (MDR) and the upcoming In Vitro Diagnostic Regulation (IVDR) with host John Spear of Greenlight Guru. Ashfaq highlights that while MDR was delayed due to COVID-19, many companies are still ignoring the mandate, risking their business viability. He warns that IVDR poses even greater challenges due to a shortage of notified bodies and the requirement for external reference laboratories for high-risk devices.

    Certification & compliancePolicy, trade & tariffs
    8 chapters

  • Global Medical Device Podcast · 30m

    Preparing for EU MDR

    Isabella Schmitt, a regulatory affairs consultant at Proxima Clinical Research, explains how medical device companies can prepare for the EU MDR, which was set to take effect in May 2020. She details the shift from the old Medical Device Directive (MDD) to the new regulation, emphasizing the need for comprehensive lifecycle safety data and the difficulties of establishing device equivalency. Schmitt advises companies to conduct gap analyses of their General Safety and Performance Requirements (GSPRs) and notes that many firms are using FDA pre-submission meetings to guide their EU clinical strategies.

    Certification & complianceValidation & product-market fit
    7 chapters

  • Global Medical Device Podcast · 38m

    #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He explains the definitions of single entity, co-packaged, and cross-labeled products, and addresses common misconceptions about the differences between drug and device quality systems. Saadeh also shares his journey of starting the podcast to maintain consistent learning and production, highlighting the importance of lifelong learning and leveraging coaching to balance technical and business aspects of the MedTech industry.

    Medical & health devicesCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 1h 02m

    #339: UDI and the State of EUDAMED

    Richard Houlihan, founder of EirMed and former head of the European Commission's IT team for EUDAMED, explains the history, delays, and technical complexities of the European Database for Medical Devices. He details the shift from legacy systems to the new UDI Device Module, highlighting the massive data collation efforts required for compliance with the Medical Device Regulation (MDR). Houlihan warns that while the database is delayed until Q2 2025, companies must start preparing now to avoid legal sales bans and vigilance reporting failures.

    Certification & complianceSourcing & supply chain
    8 chapters

  • Global Medical Device Podcast · 30m

    [LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

    Jon Speer hosts a live discussion with Evangeline Loh, Vice President of Regulatory Affairs at Emergo Group, regarding the impact of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) on the medical device ecosystem. They detail critical regulatory shifts, including the delay of the EUDAMED database to 2022, the up-classification of self-certified Class I devices under Corrigendum 2, and the severe bottleneck caused by having only 11 designated Notified Bodies. The conversation highlights the strategic advantage of securing legacy MDD certification before May 2020 to avoid MDR compliance until 2024, while also addressing the regulatory duplication and market access challenges introduced by Brexit.

    Certification & compliancePolicy, trade & tariffs
    7 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.