EU MDR Internal Audit Checklist

An internal audit checklist is an effective way to evaluate the efficiency of your processes, providing evidence of compliance, areas for improvement and gaps in your quality management system.

This section of an audit entails checking to see that customer-related processes are properly administered, as well as making sure there are procedures in place for monitoring supplier performance.

1. Documentation and Records
First step to EU MDR readiness: Audit all required documentation and records. Your quality management system (QMS) plays an integral part here, by assessing and verifying appropriate controls throughout all aspects of developing medical devices while adhering to ISO 13485 compliance.

This section of the checklist ensures that procedures exist for document identification, storage, protection, retrieval, retention time control distribution and changes as well as verification and validation reports and technical files similar to an FDA design dossier used to demonstrate that medical devices meet all applicable regulatory guidelines.

This section of the checklist ensures procedures are in place for customer-related processes, including intended uses and specified requirements being met, contracts reviewed upon incoming, feedback incorporated with CAPA system feedback gathered during service delivery, etc. These elements are vital in meeting all EU MDR regulations for CE Mark certification as well as maintaining European market access.

2. Design and Development
As an external auditor arrives, your back stiffens, your lips purse and teeth grind together in anticipation. Be it an ISO registrar or FDA auditor, they come to assess your medical device manufacturing processes and quality management system. Since they cannot review each record individually, they select a sample to review before extrapolating their findings to the entire company.

Make sure your company complies with the European Medical Device Regulation by conducting a comprehensive internal audit checklist. This audit should help verify your design and development processes are in line, with product design meeting intended uses and requirements as well as procedures in place for assigning UIDs and uploading them into EUDAMED database – one of the more linkable sections requiring thorough monitoring. Private labellers will need to also check that customer communications and feedback processes meet regulations as part of this compliance review.

3. Purchasing
EU Medical Device Regulation (MDR) recently became effective and will have a profound impact on how medical device companies operate in Europe. Due to these changes, your ISO 13485 quality management system should undergo an in-depth audit in order to comply with all new regulations.

Your purchasing process must be reviewed for any potential effects on the ability of your company to meet the new regulations, including making sure suppliers comply with them and are meeting quality management system standards.

Purchasing can be the most time-consuming component of an internal audit due to gathering data from outsourced partners, which may take an extended period to receive. Qualio’s efficient internal audit tool streamlines this process so you can spend less time collecting paperwork and more time improving quality.

4. Post-Market Surveillance
The European medical device regulations have had an enormous effect on internal processes and procedures. You should begin by mapping your existing systems and making any necessary modifications in order to meet new requirements, such as those laid out by UDI system which requires you to document how outsourced processes are managed and monitored as well as provide clear details on links between your organization and economic operators such as distributors.

Post-market surveillance requires time, energy and coordination in order to stay in compliance with EU MDR regulations. You should devise a PMS plan tailored specifically for each device class you manufacture and review it regularly for compliance.

Celegence can assist your company in meeting EU MDR compliance, helping assess your level of compliance and devise a plan for moving forward. Get in touch with us now so we can begin helping – our services are cost-effective and quick allowing you to focus on providing quality products to customers!