Case Study: Complying with New EU Medical Device Regulations on Unique Device Identifiers

SL Controls has worked on a range of projects over recent years helping clients in the medical device sector update their processes and production lines to comply with the new EU Medical Device Regulations (MDR).

This new EU directive goes live in May 2020.

One of the key requirements of the new EU MDR is that medical device products will need a Unique Device Identifier (UDI). Our experience and expertise at SL Controls mean we are perfectly placed to design, develop, and implement solutions that ensure compliance with this requirement.

An example of our experience is work we did for a multinational MedTech company while it was in the process of implementing a UDI solution across its production lines. One project we successfully completed involved updating its raw material inspection system, a crucial component of its UDI implementation.

Objectives

The project objectives were to use Cognex 5000 series cameras and Cognex Dataman D60 barcode readers to inspect raw material and assign a good or bad status to it.

We had to ensure the solution accurately verified the information printed on the raw material while also ensuring the production process uses the correct type of material.

Results

We successfully implemented a solution that delivered on the client’s objectives.

Specifically, cameras inspect the raw material and compare the information with data stored on a PLC. The solution also inspects and verifies the 2D barcode on the raw material. The raw material is then assigned a good or bad status with that information sent to a PLC.

Mick McHale, SL Controls Operations Director, said: “The new regulations on the manufacture of medical devices mean significant changes for the industry. The requirement to implement a UDI solution for all products is just one example.

“Innovative, cost-effective, and future-proof solutions can be found, however. This is what we strive for with all our clients.”

Mick McHale

Mick McHale is SL Controls' Projects Director. He has over 15 years' experience in project management and engineering design. His areas of expertise include managing complex systems automation projects and bringing them to successful completion in a range of industries including pharmaceutical, medical device, and food and beverage manufacturing. He also has expertise in process and front-end design.

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