EU MDR – EU IVDR Standard Operating Procedures
We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
According to the EU Commission amendment for the new Transitional Provisions for the MDR and IVDR (official from 20th March 2023), manufacturers need to have a quality management system in place (in accordance with Article 10(9)) no later than 26 May 2024. This is done by applying conformity assessment to a notified body where the manufacturer confirms its QMS complies with the MDR.
We can build a complete ISO 13485-compliant QMS for your Company, write specific Standards Operating Procedure (SOP) per your request, or only review your existing SOP for its compliance.
We identified 12 quality procedures (SOPs) that every Company should include in their QMS:
- Strategy for regulatory compliance – which may consist of quality objectives, processes for identification of relevant legal and GSPR requirements, choice of conformity assessment procedures, and others (see MDCG 2019-7);
- Handling communication with competent authorities, notified bodies, other economic operators, customers, or other stakeholders;
- Management of corrective and preventive actions;
- Documentation control;
- Change control;
- Organization structure, the responsibilities of the managerial staff as to critical procedures and their organizational authority;
- System for recording and reporting incidents and field safety corrective actions (art. 87 and 88) and their analysis (art. 89);
- Procedure to keep up to date the post-market surveillance system (art. 83);
- Procedure for the clinical Evaluation (including clinical evaluation plan) per Article 61 and Annex XIV, including PMCF;
- Resource management, including selection and control of suppliers;
- Risk management (Section 3 of Annex I);
- Identification and traceability of devices (art. 25)
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.