In recent discussions with professionals working for in vitro diagnostic (IVD) companies in Germany, an interesting trend has emerged. These companies are facing a growing number of inquiries from local competent authorities regarding their Class A IVDs.
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In Germany, local competent authorities (authorities based in the ‘Bundesländer’. Typically Regierungspresidien) play a critical role in oversight, and surveillance of medical devices and in vitro diagnostics (IVDs). These authorities are responsible for ensuring that manufacturers adhere to the regulatory requirements established by both European and national laws, particularly under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Here's a breakdown of their key responsibilities:
- Enforcement of EU Regulations (MDR and IVDR)
- Inspections of Quality Management Systems (QMS)
- Technical Documentation Review
- On-Site Inspections and Audits
- Market Surveillance and Vigilance
- Handling of Non-Conformities
- Providing Guidance and Support to Manufacturers
Whilst manufacturers perform post-market surveillance, competent authorities are required to perform market surveillance. Local competent authorities in Germany are tasked with enforcing the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure the safe manufacture, market approval, and post-market surveillance of medical devices and IVDs. Competent authorities ensure that manufacturers comply with these requirements throughout the product lifecycle, from design and development to market release and ongoing monitoring. A significant aspect of competent authorities’ work is the inspection of manufacturers’ quality management systems (QMS).
Competent authorities focus on class I medical device manufacturers and class A IVD manufacturers because manufacturers of higher risk class devices are subject to audits of Notified Bodies.
Why the Increased Focus?
Competent authorises always had market surveillance responsibilities, the primary reason behind this uptick in monitoring activities by the competent authorities is because compliance expectations have increased for all stakeholders including competent authorities. Aas a result authorities are conducting more frequent and in-depth inspections of manufacturers' technical documentation and quality management (QM) systems.
All IVD manufacturers have seen a significant increase in expectations, Class A IVDs, while these devices pose minimal risk to patients, must still meet the stringent regulatory requirements without the oversight of a notified body and in addition they do not benefit from transition times. Competent authorities are now actively ensuring that these low-risk devices adhere to the new requirements. What we hear from the market is that manufacturers are falling short, and authorities are not satisfied with what they are finding. Areas of deficiency are typically found in risk-management and clinical evaluation.
The Impact on Manufacturers
For manufacturers, this increased oversight has brought about a significant amount of stress. Inspections are not limited to documentation reviews; authorities are also performing on-site visits, which adds another layer of pressure. Furthermore, when non-conformities are identified, companies are often given very tight deadlines to address and correct them. Affected companies reported that deadlines given to the manufacturer vary from 5 working days (for serious and potentially safety-related non-conformities) to about 30 days (and sometimes longer depending on the subject).
The combination of unexpected visits, detailed inspections, and strict timelines for correcting issues has placed many manufacturers in a difficult position. Ensuring compliance under normal circumstances is challenging, but the added pressure of immediate corrective action has intensified the situation.
Navigating the Challenges
For IVD manufacturers, the key to managing this heightened scrutiny is preparation. Companies should ensure their technical documentation is in order and that their QM systems meet the necessary regulatory requirements regardless of the class of the device. Being proactive, rather than reactive, can significantly reduce stress during inspections. Class A devices may be low risk or accessories; however, they are enablers to the higher risk devices and there could be a significant impact to both business and patients if they were removed from the market.
Additionally, manufacturers must remain vigilant in staying up to date with any changes in regulatory requirements. Competent authorities are likely to continue their increased monitoring efforts, so ongoing compliance should be a top priority for all IVD companies, even those working with Class A devices.
Qserve does actively support IVD manufacturers of all classes in meeting regulatory requirements. We do offer gap assessments, strategic advise on how to most efficiently meet the new requirements. We support with audits, help to bring the technical documentation to compliance level and are partners to manufacturers when responding to Competent Authorities.
Conclusion
The increased monitoring activity by competent authorities in Germany is not something IVD manufacturers can afford to ignore. While Class A devices may be considered low-risk, they are still subject to the same rigorous regulatory scrutiny as higher-risk products. Manufacturers need to be fully prepared for inspections and ready to address any non-conformities in a timely manner. By taking proactive steps to ensure compliance, companies can minimize the stress associated with these inspections and continue to operate smoothly in this evolving regulatory landscape. Taking a proactive approach is an investment in continued market access across Europe and over 120 country countries that recognise the CE mark as part of their market access. Qserve is happy to help find practical solutions and be your partner in meeting regulatory requirements.
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