In Vitro Diagnostics Regulation (IVDR) Changes
Listen to the entire episode where we go over all of the important things happening in the Medical Device industry here.
Device Classification Changes
- List-based Classification to a Rule-Based
- Class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body (NB) involvement.
- MDGC 202- 16 Guidance on Classification for in vitro diagnostic Medical Devices under Regulation (EU) 2017/746.
- Establishment and Demonstration of effective Quality Management Systems (QMS).
- More stringent requirements for clinical evidence that demonstrates conformity.
- Post-Market Performance monitoring and reporting requirements.
- Introduction of Unique Device Identifiers (UDIs) for improved traceability.
Supply Chain Oversight
- Regulations covering the entire supply chain.
- Economic Operators
- Authorized Representatives
- Economic Operators
- Notified Bodies have discretionary authority to audit suppliers and subcontractors
About Seyed Khorashahi
Seyed Khorashahi has more than 25 years’ experience leading R&D teams in all aspects of developing safety-critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy.
Seyed has significant domain expertise not only in FDA and EU standards but also in software systems and hardware development for medical devices. A passionate innovator, he is a skilled collaborator as well, with recognized leadership capabilities and a relentless drive to overcome technical and business challenges. He is an influencer, consensus-builder, and a leader with success in establishing and managing relationships with external partners, executives, and internal multi-functional teams.
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- 21 CFR 210
- 21 CFR 211
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- Founded in 2000
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- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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