MDR/IVDR Compliance
In 2017, the new European Medical Device Regulation (MDR) and the Regulation on In Vitro Diagnostic Medical Devices (IVDR) came into force. These replace the existing directions on medical products.
The most important changes
MDR
- Classificaition of medical products
- Conformity assessment procedure
- Scrutiny process
- Technical Documentation
- UDI
- Market surveillance and reporting
- Quality management system
- Active implantable medical devices
- EUDAMED
- Change to OEM/PLM
- Common Specifications
IVDR
- Classification of IVDR
- Responsible person
- Notified bodies
- Technical documentation
- UDI
- Qualoity management system
- Increased demand on software
We offer solutions for the regulated market
EXCO examines your processes and documentation for compliance with the requirements of the new EU MDR/IVDR. This includes indivdual consultation with recommendationsfor action and the specific implementation of entire work packages. This means your contact person is a competent on-site project partner.
Our portfolio detailed
EXCO enables the certification of your company and the marketing of your products according to MDR/IVDR. Following our GAP analysis, we will create a concept that is tailored to you, which can be implemented by us or together with your relevant department. As a result, your QM system including the supplement management system will be harmonized in relation to regulatory requirements and you will obtain technical documentation for your products which is legally compliant.
EXCO compiles the technical documentation/product files on the basis of your existing design documentation, re-engineerings and/or developer interviews.
EXCO examines the technical documentation (according to MDR/IVDR Appendix II) and/or clinical evaluation and ensures that the product files contain no formal or technical discrepancies when they are delivered to the test laboratory.
EXCO accompanies significant changes carried out by the manufacturer’s development (deviation management) and ensures that risk management, technical documentation and clinical evaluations are up-to-date as required.
EXCO carries out the legally compliant transfer of technical product files licensed according to MDD/IVDR in accordance with the requirements of MDR/IVDR.
EXCO provides advice on possible subsidies from the state or country for activities relating to a managed MDR transfer.
- Consultation concerning the requirements derived from the MDR/IVDR on the subject of supplier management/development
- Integration of FDA 21 CFR Part 820.50 requirements on “Purchasing Controls” into existing processes and customer-supplier relationships
- Definition and implementation of outsourced processes
- Evaluation of suppliers
- Supplier and service provider qualification
- Process validation, plant qualification
- Transport validation
- Planning, execution and follow-ups of supplier audits
- Creation of quality-assuring contacts and agreements
- Risk management for products and integration of the supplier
- Management and mentoring of supplier transfers (knowledge, processes, physical relocation)
- Documentation transfer
We support you in making your products better and more secure. The new MDR offers you a range of great opportunities.
Free initial consultation
Do you have any questions about the MDR-IVDR-compliant manufacturing of pharmaceutical or medical devices?
EXCO was commissioned by the client's Regulatory Affairs and Quality Assurance department to assess the existing development process for regulatory and legal compliance with the EU IVDR.
Due to new normative, regulatory requirements and product changes, a client needed to revise the risk management files for several legacy products.