EU MDR | IVDR
ÅKRN provides guidance on how to navigate the regulatory landscape in Europe towards achieving and maintaining a CE Mark
AKRN partners with MedTech companies as a scientific and regulatory consultant to ensure that medical devices & in vitro diagnostics medical devices (IVDs) are safely placed and maintained in the EU market. AKRN’s regulatory experts can help you either while developing a new medical device or transitioning a legacy device to the EU regulations: MDR 2017/745 and IVDR 2017/746.
AKRN’s partnership supports MedTech companies in this process through the following CE Mark Regulatory Services:
Technical Documentation
- Design and manufacturing documentation
- V&V documentation
- Risk management documentation
- GSPR checklist
- IFU, Label, Declaration of Conformity
- Technical Documentation compilation
Post-market Technical Documentation
- PMS Plan and Report, PSUR
- PMCF/PMPF Plan and Report
- SSCP/SSP and lay person readability testing
- Planning of PMS and PMCF activities
- Evaluation of PMCF study needs
Clinical Evaluation (MDs)
- Clinical Evaluation Plan, including Clinical Development Plan
- Clinical Evaluation Report
- Literature Search Plan and Report
Performance Evaluation (IVDs)
- Performance Evaluation Plan and Report
- Scientific Validity, Analytical Performance, Clinical Performance Plans and Reports
Transition to MDR/IVDR
- Audits and gap assessment for MDD to MDR/IVDD to IVDR
- Implementation of gaps and transition of manufacturer documentation
Roadmap to CE-mark and regulatory strategy
- Basic product characterisation, key steps Gantt chart, preliminary estimation of timelines and budget
- MDR/IVDR product Approval Requirements
- Defining device characteristics (qualification, classification, intended purpose, WET/legacy device justification, Software as Medical Device, combination products)
Device portfolio prioritization
- For companies with a large portfolio of products under development/transitioning to MDR/IVDR
- Revision of preliminary clinical evidence, SOTA and TD status for selection of candidates closer to meeting requirements for CE-mark
Assessment of sufficient clinical evidence
- Strategies for legacy and well-established technologies
- Evaluation of need of PMCF/PMPF study
- Clinical evidence search and analysis
NB/CA/Economic operators
- Notified Body management: selection, support in responses to non-conformities and document corrections
- Communication and liaison with National Competent Authorities
- Registration of Economic Operators: from national authorities to EUDAMED