Medical device manufacturing: product traceability according to ISO 13485 and EU MDR

Medical device manufacturing

Every day medical device regulations undergo new changes in order to help products stay safe and effective. One of the last main changes (MDR – 26/05/2021) is the reinforcement of end-to-end traceability for medical devices.

Traceability is the capacity to identify and trace the history, distribution, location and application of products, parts and materials.

It is a crucial part of the medical device manufacturing process and plays a critical role in ensuring product quality and safety. That is why the medical device contract manufacturer that you use should closed-loop traceability framework.

The function of a traceability for medical device framework is to provide a clear roadmap of the medical device manufacturing process, encompassing supply and distribution. It details why, how, where and when a product has been manufactured.

Manufacturers must have a sufficient quality management system to ensure supply chain control from raw material purchasing through postmarketing surveillance.

What does ISO 13485 require for medical devices traceability?

The needs for purchasing control in the medical device supply chain are outlined in the ISO 9001:2015 and 13485:2016. ISO 13485 requires organization to document procedures for traceability for medical device. These procedures will define the extent of traceability in agreement with applicable regulatory requirements and the records that need to be maintained.

What does EU MDR require for medical devices traceability?

The EU MDR requires total lifecycle traceability between all stages of medical device manufacturing, development and post-market activities. Demonstrating traceability throughout the product lifecycle, known as closed-loop traceability.

The EU MDR mandates all third-party suppliers and manufacturers involved at any stage of a medical device’s lifecycle to undergo an audit of their QMS to demonstrate compliance with traceability requirements.

To keep track of devices through every lifecycle stage, a device identifier will be assigned and all production series will be marked with this Unique Device Identification (UDI), which is entered into the EUDAMED database.

The purpose of EUDAMED is to create an accessible repository of device-related information for patients, regulators, notified bodies, and manufacturers to access data for medical devices being marketed in the EU and help improve overall post-market surveillance.

UDI information must:

  • Be placed on the medical device’s package or label.
  • Follow globally used formats.
  • Include the EC representatives’ detailed information, including name, address, and symbol.
  • Be published electronically to the manufacturer’s website and also be available in print.

Another significant change that is introduced in the regulation is a new economic operator system. Under EU MDR, economic operators now include manufacturers, authorized representatives, importers, and distributors. These entities will be expected to take on an increased level of responsibilities throughout the medical device manufacturing supply chain process.

In addition, new requirements for economic operators include verification of compliance, cooperation in complaint handling and field safety corrective actions, and, of course, cooperating with manufacturers and Competent Authorities in traceability for medical device.

Why does traceability in medical device manufacturing matter?

Here the main reasons why traceability is important in the medical device manufacturing:

  1. Supply chain visibility. When traceability is applied throughout the manufacturing process (design, production and sale), a manufacturer can quickly and easily trace from across the supply chain the origin of the materials and components used in the manufacture of a medical device.
  2. Quality control. Traceability for medical devices is a key part of ISO 13485 and ISO 9001 international manufacturing quality standards, and a comprehensive traceability framework helps to prove compliance with these standards. This traceability and the various formats that it takes (e.g. labels, laser etching, barcodes, moulded stamps), also helps fight against counterfeiting. It guarantees product authenticity and protects brand reputation.
  3. Risk Reduction. A comprehensive traceability system ensures better recall management. In the case of any issues, such as a defect (which doesn’t necessarily have to come from the manufacturing process), a manufacturer can react quickly if it has a detailed supply, production and distribution history on record. Materials and components can be easily tracked and replacements quickly matched.
  4. Data-driven insights. Reliable, trackable system where companies can leverage data-driven insights to make better decisions that allow them to outperform the competition.
  5. Streamlined audit preparation timeline. The ability to track and properly record documentation throughout a device’s lifecycle and provide all information with full transparency is a key competitive advantage as it improves efficiency and reduces the chance of costly fees associated with noncompliance.

How traceability affects the choice of a contract manufacturer for your medical device

When you choose a contract manufacturer, you should ensure that they operate a comprehensive traceability framework

The traceability framework should comprise a range of processes and features that help ensure product quality and safety. These include:

  • The checking and inspection of all components when they arrive at the medical device manufacturing base. After the components have passed inspection, they should be assigned a receipt ID. The component number, quantity and lot number should be recorded on a materials requirement planning (MRP) system.
  • When a production batch is raised, the MRP system should generate a component picking list in relation to the batch number level. The components selected are then issued to the manufacturing job.
  • Each medical device production job should be allocated a production batch number, which can be clearly linked to individual component data.
  • Any components that remain following the completion of the medical device manufacturing job should be logged on the MRP system and returned to the relevant stock batch.
  • Finished medical device products should be dispatched with a certificate of conformity that shows the lot number, production date, sterilisation date and certificate number, if applicable. 

All Creanova medical device product records are held as standard for 10 years from the date of last component production.

Creanova is ISO 13485 certified and operates a comprehensive traceability framework that includes all the features listed above. This focus on traceability for medical device is part of our commitment to the highest quality standards in each step of our end-to-end medical device development.

As an experienced contract medical device manufacturer, we serve our clients with a wide range of services, from medical device design to development and contract manufacturing. 

At Creanova, we have the traceability system to satisfy all of the regulatory requirements of your medical equipment project. To find out more about how Creanova can help you with your medical product manufacturing, development and design, get in touch.