Regulatory pathway for Medical Devices
QbD Timeline 2019 2018 France 2017 Colombia 2016 QbD Sales office USA Spain Software 2013 & Mexico The Netherlands 2011 Belgium +200 Employees +50 Clients
QbD Fields of action Regulatory affairs Validation expertises Project management & support Quality assurance
QbD client portfolio Pharma Biotech Medical devices Cosmetics
Steven Vinkx Medical Device QA Lead auditor & regulatory project engineer ISO13485:2016 QMS implementation Certification regulatory strategy Project management Training
Medical Device Life Cycle Scope of regulatory compliance ISO 13485:2016 Design & Verification & Design Device Post Ideation Feasibility Development Validation Transfer production Market Manufacturing Design & Development Research Change Control Design control Product registration process PMS Regulatory approval
Regulatory strategy Intended market Three factors to MD versus IVD determine go-to-market regulatory strategy Intended use & risk
Intended market
Europe : CE marking - marking
Medical Device or In Vitro Diagnostic ? Medical Device Regulation intended by the manufacturer to be used … for human beings …. for medical purposes … does not achieve its principal intended action by pharmacological, immunological or metabolic means … in or on the human body, but which may be assisted in its function … In Vitro Diagnostic Regulation … medical device to be used in vitro for the examination of specimens, …. derived from the human body …. solely or principally for the purpose of providing information …..
Medical Device or In Vitro Diagnostic ? Origin of input data? Software Integral versus MD or IVD ? -> can be both standalone More devices / platforms than you might expect!
Software - Medical Device or IVD ? 1 Algorithm that generates a risk score to trigger care processes MD based on respiratory rate, heart rate, blood pressure, … medical purpose in vivo monitoring 2 Bio-informatics intended to analyze sequencing data coming IVD from patient cancer genomes. allows detection of genome alteration IVD input supports diagnosis and treatment decisions
Software - Medical Device or IVD ? 3 Software to be used for hospital staff planning and invoicing Generic no medical purpose Qualification & classification guideline – MDCG (11/2019)
Risk based classification FDA vs MDR/EU Based on intended use / claim Correlation claim versus risk Higher class for higher risks
Europe : Transition to MDR May 2021
Key MDR changes
Key MDR changes UDI EUDAMED (postponed) Classification
Impact of COVID-19 pandemic
Requests for «exceptional use» “Compassionate use” On case-by-case patient & MD basis (e.g. respiratory devices) Derogation requests Request for a derogation on conformity assessment of NEW - Medical Devices & IVD’s - For the purpose of multiple patients - Under supervision of National Competent Authority (FAGG)
IVD Derogations
IVD for Covid-19 SARS-CoV-2 Virus testing Antibody testing Genetic material (PCR) Immune response blablabla Lower effectiveness & sensitivity Surface antigens Fast result Mostly automated Population Screening Diagnosis & Treatment Context & Intended purpose !
MD (&PPE) Derogations
More flexible regulatory approval Medical Device Class Is Non-CE marked Surgical Masks are allowed under strict conditions (sterile) Availability only during crisis No use of regular distribution channels
More flexible testing regime Scope of regulatory compliance ISO 13485:2016 Design Device Post Design & Verification & Ideation Feasibility Development Validation Transfer production Market Manufacturing Design & Development Research Change Control Design control Product registration process PMS Regulatory approval
More flexible testing regime Design & Verification & Development Validation Harmonized Standard Alternative Testing Protocol EN 14683 Other standards also accepted YY 0469:2011 and YY/T: 0969-2013 ASTM F2100
Free ISO standards https://www.iso.org/covid19
Medical Device Life Cycle Scope of regulatory compliance ISO 13485:2016 Design & Verification & Design Device Post Ideation Feasibility Transfer production Market Development Validation Manufacturing Design & Development Research Change Control Design control Product registration process PMS Regulatory approval Start in time ! Determine the applicable legislation Determine intended use & classification Implement lean & efficient QMS
Thank you
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