The UDI and Serialisation Requirements of the New EU MDR

The clock is well as truly ticking on the introduction of the new EU MDR (Medical Device Regulations). The process of implementing this new EU directive started in 2017, with it scheduled to come into force on 26 May 2020, i.e. less than a year from now.

EU MDR represents a significant change to regulations governing the development, regulatory approval, and manufacture of medical device products. It has several different aspects including:

  • Many products are being reclassified using a new risk-based classification system
  • There are now stricter pre-market controls
  • There is a new requirement for medical device product manufacturers to establish a post-market surveillance system for the products they produce
  • And more

One of the key areas that is changing under the new EU MDR, however, is the requirement to have Unique Device Identifiers (UDI) on all medical devices.

Unique Device Identifiers

The concept of including UDIs on the labels of medical device products is not new, of course. After all, it has been necessary to include UDIs on MedTech products marketed in the US since 2013.

The new European regulations are more stringent, however, as they will apply to a broader range of products than the rules in the US.

If you already ship to the US or manufacture according to FDA standards on UDIs, you will have less to do to achieve compliance with the new EU MDR. However, you will still have to make changes.

In other words, the new UDI rules will impact all medical device manufacturers making products for the EU market. Here are the key things you need to know.

Why is There a UDI Element in the New EU MDR?

There are three main reasons for including a UDI element in the new EU MDR:

  • Improves track and trace capabilities through the entire product lifecycle
  • Combats counterfeiting
  • Enhances transparency

What Are the New UDI Requirements?

In very brief terms, the new UDI requirements involve creating a UDI for each medical device product you manufacture. You must send this UDI to the EU Database for Medical Devices (EUDAMED).

In addition, the UDI must also be part of the product label of each medical device.

When Do the New Rules Apply?

  • Sending UDI information to the EUDAMED – you must do this by May 2020 when the rest of the new EU MDR comes into force
  • UDI included on product labels for Class III products and implants – more time is being given to manufacturers to include UDIs on product labels given the scale of the challenge this can present. For Class III products, the deadline is May 2021.
  • UDI included on product labels for Class IIa and IIb products – May 2023
  • UDI included on product labels for Class I products – May 2025

What Are the UDI Requirements?

  • The UDI must appear in plain text on all packaging parts of a product;
  • It must be machine-readable; and,
  • It must feature two components – a Device Identifier (DI) and a Production Identifier (PI or GTIN).

What Does the UDI-DI Element Contain?

The UDI-DI identifies the product, plus it contains the product’s master data including:

  • Product name
  • Manufacturer name
  • Type of control
  • Quantity in a pack
  • Size
  • Warning notices (next to the serialisation requirements, this is one of the biggest impacts of the new UDI rules)

What Does the Production Identifier Contain?

  • Date of manufacture
  • Expiry date
  • Serial number or lot number
  • And more

The serial number for some products will need to be an individual serial number. For others, however, the serial number will be a batch number. Either way, this represents a substantial change to the previous system.

The Serialisation Solution to the UDI Requirements of EU MDR

For most medical device manufacturers, the most effective way to comply with the new UDI requirements of EU MDR is to implement a new serialisation solution or update an existing one.

This is necessary because of the large amount of new information that is required on medical device product labels. It’s also necessary because the new requirements present a significant data collection, storage, and transmission challenge for MedTech manufacturers.

Working with a specialist serialisation solution provider will ensure a smooth transition to compliance with the new regulations. Find out more by contacting SL Controls today.