In Vitro Diagnostic Regulation (IVDR) Changes 2021
Listen to the entire episode where we go over all of the important things happening in the Medical Device industry here.
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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.
Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
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