Medical devices or in vitro diagnostic devices that are placed on the European market, must meet the requirements of their respective Directives or Regulations. Conforming products receive the CE mark label as evidence of compliance.
MARACA International offers a complete list of services to assist the manufacturer in obtaining the CE mark for his products.
These services for CE marking include:
- Full management of the manufacturer’s regulatory affairs activities. Small or medium size manufacturers can outsource all or part of their regulatory activities to MARACA International for effective regulatory affairs management.
- General consulting and training on the medical device (MD) and in vitro diagnostic device (IVD) Directives and new MDR and IVDR Regulations and their impact on your business.
- Hands-on training on specific parts, such as risk management, clinical evidence, performance evaluation report and the composition of technical documentation using MARACA International templates. This will facilitate your conformity assessment and understanding of the requirements for CE marking.
- Review of the technical documentation to identify any deviations from the regulatory requirements.
- Composition of technical documentation and design dossier for notified body assessment.
- Review of your instructions for use and product labels. Advise in the design of labeling, Unique Device Identifier (UDI) and optimization for translation.
- Gap analysis audit of the quality system versus the requirements of the MD Directive/Regulation or IVD Directive/Regulation and ISO13485.
- Assistance in notified body selection and in the preparation for a conformity assessment by the notified body.
- Advice in the classification of medical devices, IVDs, software, health applications and borderline products.
- Composition of performance evaluation plans and reports.
- Organization of clinical performance evaluation studies, including near-patient and self-testing studies.
- Composition of clinical performance evaluation study plans and reports.
- Assistance in the composition of clinical data, statistical planning, data management and study monitoring.
- Interactions with the competent authorities.
- Notification of CE marked products to the national competent authorities.
- Expert defense support for regulatory actions by authorities.
- Management of incidents: Health hazard assessment, incident notification, recall and advisory notices.