Contact an IVD Device International Regulatory Expert

IVD Device Experience

MCRA’s team has successfully navigated hundreds of international regulatory submissions. Our capabilities extend to European, Australian, and Canadian markets, successfully remediating Technical Files and Clinical Evaluation Reports (EU CER) for compliance with MEDDEV 2.7.1. Rev. 4 for medical devices across the industry.

MCRA is a world-class provider of regulatory strategy and advice for IVD devices, including:

  • Anemia in vitro diagnostics
  • Antimicrobial resistance marker genetic in vitro diagnostics
  • Antimicrobial susceptibility (AST) in vitro diagnostics
  • Autoimmune disorder in vitro diagnostics
  • Bacterial infection in vitro diagnostics
  • Blood clotting disorder in vitro diagnostics
  • Breath in vitro diagnostics
  • Cancer in vitro diagnostics
  • Cancer monitoring in vitro diagnostics
  • Cancer Predisposition Risk Assessment in vitro diagnostics
  • Cardiovascular disease in vitro diagnostics
  • Chemistry analyte in vitro diagnostics
  • Companion Diagnostic (CDx) in vitro diagnostics
  • Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection in vitro diagnostics
  • Diabetes in vitro diagnostics
  • Digital Pathology in vitro diagnostics
  • Drugs of abuse in vitro diagnostics
  • Fever-causing infection in vitro diagnostics
  • Food and other allergy in vitro diagnostics
  • Fungal infection in vitro diagnostics
  • Gastrointestinal bleeding in vitro diagnostics
  • Gastrointestinal pathogens in vitro diagnostics
  • Gene expression profiling in vitro diagnostics
  • Gene expression profiling test system in vitro diagnostics
  • Genetic health risk (GHR) in vitro diagnostics
  • Heavy metal in vitro diagnostics
  • Immune deficiency in vitro diagnostics
  • Immunoglobulin light chain amyloidosis in vitro diagnostics
  • Immunohistochemistry (IHC) in vitro diagnostics
  • In vitro diagnostic instrumentation
  • In vitro diagnostics supported by over the counter (OTC), point of care (POC), or CLIA waiver studies
  • Infectious disease in vitro diagnostics
  • Latent viral infection in vitro diagnostics
  • Liquid biopsy in vitro diagnostics
  • Medical Countermeasure in vitro diagnostics
  • Minimal Residual Disease (MRD)/tumor burden in vitro diagnostics
  • Neural tube defects in vitro diagnostics
  • Next generation sequencing based tumor mutation profiling in vitro diagnostics
  • Organ damage/disfunction in vitro diagnostics
  • Pharmacogenetic/Pharmacogenomic in vitro diagnostics
  • Postnatal chromosomal copy number variation detection in vitro diagnostics
  • Primary hemostatic function in vitro diagnostics
  • Respiratory pathogens in vitro diagnostics
  • Semen analysis in vitro diagnostics
  • Sepsis and septic shock prognosis in vitro diagnostics
  • Sexually transmitted disease in vitro diagnostics
  • Specimen collection devices
  • Therapeutic Drug Monitoring (TDM) in vitro diagnostics
  • Traumatic brain injury (TBI) in vitro diagnostics
  • Viral infection in vitro diagnostics
  • Women’s health in vitro diagnostics

International Regulatory Services

MCRA has industry leading specialization in the full spectrum of IVD medical devices. Over the years, we have supported hundreds of clients seeking regulatory designations, clearances, and international registrations with Technical Files, Dossiers and CERs in OUS markets.

Our comprehensive regulatory services include:

  • Agency/Notified Body interaction
  • Clinical testing plan
  • Design dossier and technical file gap assessment
  • Device classification
  • Device listing
  • Due diligence services
  • Establishment registration
  • European Technical Files and Clinical Evaluation Reports (EU CER) compliant to the EU MDR
  • Gap Assessment of Key Chemical/Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)
  • Global regulatory strategy
  • Import/export
  • Labeling
  • Medical device reporting
  • Mock audits
  • Notified body submission/Response
  • Post-market surveillance
  • Pre-clinical testing plan
  • Quality system gap assessment
  • Regulatory file letters
  • Regulatory landscape assessment
  • Training (EU MDR)

Contact an IVD Device International Regulatory Expert