Start the work early
Starting now is a must. There are many details about transition in the regulatory framework for manufacturers to take into account and make a strategy. For example:
- Product portfolio review: what products should be transferred to MDR? Decisive may be the status of existing documentation.
- GAP analysis of quality system, product documentation and inventory classification rules.
- Ensure competence: educate employees and associate experts about the business. MDR requires a regulatory expert person to be employed, or linked to the company in case of smaller companies.
- Ensure access to the appropriate Notified Body: Many more manufacturers will need to interfere with Notified Bodies, NB:s, for Quality System Review and/or Technical Product Documentation. Right now, they apply for NB:s That wish for appointment (designation) against MDR / IVDR. In recent years, the number of NBs has decreased sharply and the pressure on the remaining ones is increasing.
Knightec can support manufacturers in work with strategic plans and who to best meet the new requirements. We have extensive experience of doing investigations and GAP analyses to create/update technical product documentation, create/update quality management systems, etc. within Medtech. Knightec´s Compliance Optimized business focuses around this.