Look at the label of almost any IVD reagent kit, and you will find one company name: the legal manufacturer. What the label does not tell you is who actually made the contents, such as specific antibodies, the latex particles, special proteins or the control serum inside. Very often it is a specialist company you have probably never heard of. This is normal in our industry and not a sign of poor quality. But laboratories, distributors, and smaller IVD companies should consider this because it can affect supply, quality, and responsibility.
What contract manufacturing means in IVD
Contract manufacturing means one company makes a product or a component, and another company sells it under its own name.
In IVD, this happens at two levels:
- Raw materials and components. Antibodies, antigens, enzymes, latex and magnetic particles, membranes for lateral flow strips, calibrator and control materials.
- Finished products. A complete reagent kit or rapid test, made to the brand owner's specification and packed with the brand owner's label.
Large suppliers buy at both levels. A smaller IVD company may outsource almost everything except label design and sales.
Why even the big suppliers buy in
Running a modern analyser system means offering a wide test menu. No company can develop and produce every antibody or control material at a reasonable cost within an acceptable time frame, and customers also require state-of-the-art products which are often available only from certain specialist suppliers.
Specialist manufacturers fill this need. Some have spent decades on one narrow technology, such as monoclonal antibodies for cardiac markers or latex particles for turbidimetric assays. Buying their material is often faster and better than starting from zero.
The market is substantial. Kings Research values IVD contract manufacturing at around US$ 20 billion (Kings Research), and it continues to grow.
The name on the box identifies the legal manufacturer
The name on the box matters because it identifies the legal manufacturer responsible for all aspects of the product.
In Europe, under the In Vitro Diagnostic Regulation (EU) 2017/746, and in the USA, where the Food and Drug Administration (FDA) sets the rules, the manufacturer is not only the company that makes a device, but also the company that has it designed or made by others and markets it under its own name or trade mark.
That company carries full responsibility: technical documentation, performance evaluation, quality management, post-market surveillance, vigilance reporting, and CE marking or FDA 510(k) clearance. It cannot pass this responsibility to its supplier.
A distributor who puts its own brand on a test also becomes the manufacturer in the eyes of the law. Article 16 of the IVDR says this directly, unless an agreement names the original manufacturer on the label and keeps it responsible (IVDR Article 16).
The regulation hardly mentions the contract manufacturer. Its obligations come through the contract with the legal manufacturer, and these companies often have dedicated purchasing groups to ensure contracts are fulfilled correctly.
Why the same product may sometimes carry two brands
Because one specialist may supply several companies, the same finished product, antibody or control material can reach the market under more than one brand. Sometimes the finished kits are almost identical in terms of label.
This is useful for a laboratory to know. A change of reagent brand does not always mean a change of the underlying material, and a quality problem at one specialist supplier can affect several brands at the same time.
Contracts
If you are the legal manufacturer, the quality agreement with your contract manufacturer is the most important document in the relationship. It should cover at least:
- The supplier's quality management system.
- The right of your notified body to make unannounced audits at the supplier.
- Change control: no change to materials, process or site without your approval.
- Traceability of lots and raw materials.
- Access to records, validations and risk management files.
- Support for complaints, vigilance and post-market surveillance.
- Supply continuity: notice periods, safety stock and a second source where possible.
These points follow the usual recommendations for MDR and IVDR quality agreements (Outsourced Pharma), but this is not an exhaustive list.
Questions to ask a supplier
Whether you are a laboratory, a distributor or a young IVD company, these questions are worth asking:
| Question | Why it matters |
|---|---|
| Who is the legal manufacturer? | This company carries the regulatory responsibility. |
| Is any critical material single source? | One failure can stop supply. |
| How are changes to raw materials notified? | Silent changes can shift results. |
| Where is the product made? | Site, country and certification. |
| What stability data exist? | Shelf life and storage conditions. |
Make or buy
For a smaller IVD company, the real question is often make or buy. Making gives control, but needs people, equipment and time. Buying is faster, but you depend on a partner you do not fully control.
There is no single right answer. It depends on the product, the volumes, the regulatory class and the skills you already have. What matters is to decide consciously and to manage the supplier as part of your own quality system.
Regulatory aspects
It is recommended to seek advice from specialists for questions about FDA and IVDR issues, prior to proceeding with a new project.