IVDR: Setting a New Benchmark for Supplier Management

Supplier quality management is a core aspect of any manufacturing company, and especially so in the medical device manufacturing industry because of its criticality to patient health and safety. In fact, the recent pandemic has highlighted this importance even more and regulatory bodies are striving to upgrade regulatory and compliance requirements to ensure product quality and patient safety.

Interestingly, IVDR (In Vitro Device Regulation) does not specifically use the term supplier as such to be regulated. However, it is indirectly indicated in many places that manufacturers must monitor, control and audit their suppliers and.

Types of Suppliers

In a way, even a manufacturer is a supplier for the distributor or the end-user. But from a regulator’s perspective, the term “supplier” may refer to any one of the following:

• Outsourcing partner
• Subcontractors such as sterilization facilities or packaging facilities, etc.
• Raw material or component suppliers
• Sister companies or internal suppliers
• Notified Bodies also play a part in supplier management.

The Role of Suppliers in Ensuring Safety

The to-be-released IVDR sets benchmarks for the safety and efficacy of a product not only addressing the manufacturer alone but the entire supply chain, including the producers, customers, and the users. It requires Notified Bodies and competent authorities to be “more” stringent and “more” focused on complying with the extensive regulations.

The new IVDR regulations can be viewed from three perspectives:

• Manufacturers
• Competent authorities
• Notified bodies

Manufacturer Perspective

Article 10 clearly mandates that a manufacturer has sufficient control over its suppliers or subcontractors and incorporates supplier management in its quality management system implemented in each of its premises. In short, every single location must apply Article 10 Resource Management and provide evidence for it.

As per the technical documentation requirement mentioned in the annex under ‘Design and Manufacturing Information’, the manufacturer is expected to include information about the sites where the actual manufacturing is happening. This includes its subcontractor sites where the conversion from raw material to the actual product is happening. This must also incorporate information and credentials about the raw material supplier or of other services such as calibration, biocompatibility service provider, packaging process, and so on.

Competent Authority Perspective

Article 88 Market Surveillance Activities makes it very clear that the Competent Authority or a Notified Body is authorized to perform an announced or unannounced audit at the manufacturer’s premises, including suppliers or subcontractors, as a regular activity or if they suspect non-compliance. They may determine this based on the sampling size and the criticality of the associated risks.

Notified Body Perspective

There are two specific annexures addressing Notified Bodies – Annex 7 and 9. It makes it very clear that any Notified Body auditing a manufacturer, its authorized rep, or their supplier, has to be independent and impartial. They cannot be a consultant or should not have any other link to the manufacturer.

Clause 4.5.2 specifies that a Notified Body (while auditing the manufacturer’s sites) should identify the links and responsibilities between the manufacturer and their suppliers to determine the risks and their involvement in the actual manufacturing of the product. They are also expected to audit the suppliers if they discover that the conformity of a finished product is significantly influenced by the activity of the supplier.

For example, sterilization is an important process in the manufacture of single-use sterile ducts. If sterilization is being outsourced to a third-party subcontractor, the Notified Body must audit them at regular intervals.

Surveillance

The clause also stipulates that the Notified Body must audit surveillance activities and post-certification monitoring activities of manufacturers. In this context, if identified that suppliers, subcontractors, service providers, etc, can influence product testing, monitoring, and compliance, then they must also be audited.

A Lifecycle Approach

IVDR emphasizes a lifecycle approach which doesn’t end with just building the product but continuing to monitor it after being released in the market using product quality complaints and feedback to improve the product. Remember, even an adverse event report or a CAPA is data input for continuous improvement.

Supplier management also becomes important to the lifecycle approach. This includes:

• Supplier evaluation to ensure that they meet your quality needs
• A contract or agreement specifying the roles and responsibilities
• A score to identify whether they are a critical and competent supplier

The Role of a Next-Generation EQMS

The complexity of supplier management, as specified by IVDR, needs automation of the entire process. An EQMS solution, such as the one from ComplianceQuest, is designed to manage the entire product lifecycle and includes a dedicated module for supplier management. It helps with the evaluation, contract management, collaboration, performance evaluation as well as the engagement with suppliers for investigations and CAPAs

It takes a risk-based approach to supplier management, in identifying critical suppliers and ensuring they continue to keep pace with your requirements for product quality and patient safety.

An automated supplier management solution easily provides overall visibility into the supply chain in addition to managing supplier audits and inspections. An electronic supplier management solution, such as from ComplianceQuest, aids manufacturers in data quality and integrity and ensures that any changes are controlled that impacts the supply of materials or the finished product and helps with post-market surveillance through complaints management, and other data-driven feedback management.

ComplianceQuest EQMS also provides a document management system that can help improve overall supplier management as envisaged by IVDR by ensuring suppliers have access to all the latest specifications and requirements.

IVDR aims to improve the safety of in-vitro diagnostic medical devices as well as improve visibility and traceability across the value chain. To be effective from May 2022, it lays stress on automating quality management processes across the entire supply chain to minimize risks through greater visibility of data and processes.

For a detailed understanding please refer to our webinar titled ‘Is IVDR setting a new benchmark for Supplier Management’.