Documentation

The initial step in a Notified Body audit involves reviewing technical and Quality Management System (QMS) documentation. Therefore, prior to the audit, it's crucial to prepare documentation of the highest quality. This documentation should provide scientific proof of the device's safety and effectiveness (performance). If the device carries any risks, they must be addressed. The technical documentation should clearly show that the benefits of the device outweigh its risks.

Quality Management System documentation should clearly show that all processes implemented by the manufacturer are aimed at creating safe and effective devices. Additionally, QMS documentation must outline how the manufacturer plans to handle any potential issues related to the medical device.

The documentation is more about logic and scientific integrity than just about filling all boxes in a checklist. It's like telling a story about how the product was developed, tested, and kept safe after it hit the market. This story needs to make sense, with no gaps or mistakes.

Additional steps to get ready for the audit

Preparing for an audit involves more than just organizing technical documentation and Quality Management System (QMS). Medical device companies must also meet additional requirements to ensure compliance. This includes appointing an Authorized Representative for non-EU companies, obtaining Basic Unique Device Identification (UDI) and Unique Device Identifiers (UDIs), registering on EUDAMED, and acquiring a Single Registration Number (SRN). These steps are necessary for demonstrating regulatory compliance and facilitating a smooth audit process.

Notified Bodies require that medical device manufacturers complete these steps before approaching them for audits and certifications. By completing these requirements beforehand, manufacturers demonstrate their commitment to regulatory compliance and streamline the audit process with Notified Bodies.

Communication

Once all preparations are complete, the medical device company must seek out a suitable Notified Body (NB). The chosen NB must possess an appropriate scope of accreditation, be willing to collaborate with the company (although it may decline), and be available to meet the company's timelines.

Communication is important. Establishing clear channels with the Notified Body is necessary. It's not just about presenting documents but engaging in a constructive dialogue. This interaction not only addresses immediate concerns but sets the stage for a collaborative and ongoing relationship.

That said, keep in mind that Notified Bodies are prohibited by EU regulations from providing consulting services or detailed explanations. Therefore, companies should not expect NBs to offer consulting during the audit process or explain what exactly the manufacturer should do to rectify deficiencies found during audits.

Audits and inspections

Once all preparations are complete and an agreement has been reached between the manufacturer and the Notified Body (NB), the next steps in the certification process involve the audit of documentation and an on-site inspection. This phase ensures that the manufacturer's technical documentation and quality management system (QMS) align with the requirements outlined in the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).

During the audit of documentation, the NB thoroughly reviews the manufacturer's technical files, design dossiers, and other relevant documentation to assess compliance with regulatory standards. Following this, an on-site inspection should be conducted to verify the implementation of the QMS and the manufacturing processes. This on-site inspection provides the NB with firsthand insight into the manufacturer's facilities, procedures, and practices, allowing for a comprehensive evaluation of compliance with regulatory requirements.

Audits and inspections conducted by Notified Bodies are crucial steps in the certification process for medical device manufacturers seeking to place their products on the EU market.

Data and process integrity

During audits and inspections conducted by Notified Bodies, the integrity of data and processes is of great importance. Every claim made by the manufacturer must be substantiated with evidence. This means that there should be no assertion left unsupported; each claim must be backed by robust proof.

Coherence and consistency across all processes are essential. Manufacturers must ensure that their processes align seamlessly and that there are clear records documenting each step. Simply having Standard Operating Procedures in place is not sufficient; they must be demonstrated to be effective and actively implemented, rather than existing merely as formalities to meet regulatory requirements. By upholding data and process integrity and providing comprehensive evidence to support claims, manufacturers can strengthen their compliance with regulatory standards and increase their chances of successful certification during audits and inspections.

Certificate

Once all the necessary steps outlined above are completed and regulatory requirements are strictly adhered to, the manufacturer will receive certification from the Notified Body. This certification signifies that the medical device meets all the requisite standards and regulations, allowing it to be introduced into the European market. With the NB certificate in hand, manufacturers gain access to the vast European market, providing them with opportunities for distribution and commercialization of their medical devices across the European Union.