In May 2017, the European Union’s In Vitro Device Regulation (IVDR 2017/746) went into effect, replacing the In Vitro Diagnostic Device Directive (IVDD). The new regulation is more comprehensive than the IVDD and was introduced to reduce inconsistencies in the way directives were interpreted by member countries. This new regulation introduces risk-based classification rules for in vitro diagnostic (IVD) devices and strengthens the role of notified bodies (NBs) in their oversight of the supply chain, including unannounced audits of critical suppliers and subcontractors. NBs are organizations designated by EU member states to conduct conformity assessments against the specific requirements of a directive or regulation.
Under the new regulation, manufacturers are subject to random unannounced audits at least once every 5 years, a change from every 3 years under the IVDD. These audits may also include a manufacturer’s supplier if that supplier is considered crucial for the manufacturing of the IVD devices. The risk-based classification introduced under the new regulation also increases the scope of devices that require NB involvement and are thus subject to unannounced audits. Under the directive, approximately 20% of devices required NB conformity assessments, whereas under the new regulation, devices classified as Class B-D, approximately 80% of devices currently on market, will require NB involvement. These regulations apply to all manufacturers that sell devices into the EEA market, regardless of the location of the manufacturing facility. Manufacturers have a five-year transition period to certify their products under the new regulation. After certification under the new regulation, products will then be subject to unannounced audits by NBs.
Unannounced audits are simply that – audits occurring without prior notice. These checks are in addition to – not in lieu of – scheduled surveillance audits. Under the new regulations, NBs have a right and duty to conduct unannounced audits. Unannounced audits are designed to ensure that a product is being manufactured in compliance with the quality management system.
Companies selected for audit must provide full access to their manufacturing processes, as well as quality, batch, and purchasing records. IVD manufacturers, and if appropriate, their critical suppliers or subcontractors, must comply.
The IVDD was passed in 1998 to regulate the free movement of IVD devices within the EEA. By 2010, the identification of several weaknesses within the directive, the development of new technologies, and a need to align with international guidelines led to public consultations to assess a need to update the IVDD. The PIP scandal also highlighted weaknesses in the NBs’ system of certification.
In 2010, French breast implant manufacturer Poly Implant Prothèse (PIP) was exposed and fined for using industrial-grade silicon instead of medical-grade in its products. A 2012 UK report found that industrial-grade implants are twice as likely to rupture, causing scar tissue, pain, inflammation, or changes to the shape and feel of the breast. Approximately 300,000 women received PIP implants, and those who suffered leakage received €3,000 – roughly $3,400 – each. European courts ordered both PIP and the German firm that granted the implants’ safety certificates to pay the compensation totaling nearly €6 billion.1
To increase the safety of IVD devices and prevent future scandals, the European Commission passed recommendations that all IVD and medical device manufacturers must submit to NB-conducted unannounced audits.
To be ready for unannounced audits, manufacturers should develop and implement concrete plans to ensure these events run smoothly. Manufacturers must educate their suppliers and subcontractors that any problems during an audit can pose a risk to compliance certificates. Running mock audits to identify possible weaknesses in compliance and production processes could be helpful.
Most importantly, manufacturers should review and revise existing quality contracts – or create new ones – with their critical raw material suppliers and subcontractors. At minimum, contracts must ensure auditors won’t be turned away and will receive full access to the production chain and pertinent records.
Maintaining an open dialogue with your critical supplier will be key to ensuring they have the correct quality policies in place and are prepared for unannounced audits. Some points to consider are:
To be most effective however, suppliers and subcontractors must do more than merely open their doors to NB auditors. They must actively take steps to help manufacturers consistently meet regulatory requirements.
As a critical raw material and component supplier to the IVD and medical device industries, we understand the need for supply chain transparency, critical control parameters in manufacturing, and a documented manufacturing process that has stringent quality control procedures. We recognize the importance of these unannounced audits, and we’re ready to partner with you and help you prepare. Our teams of over 10,000 quality and supply chain professionals have established best-in-class programs to ensure quality compliance and effective supply chain management.
You can count on us for high quality, fit-for-use products that offer the consistency and documentation necessary for your IVD and medical device manufacturing.
Please visit our Risk Mitigation home page for complete information on our programs for supply chain, quality, risk assessment and contract manufacturing.