The impact of new European Medical Device Regulations

Medical device and diagnostic manufacturers are preparing to realize compliance

The New Regulation (EU) 2017/745 for medical devices (MDRs), which went into effect on May 26, 2021, is a major update to the regulatory framework in the European Union (EU).

Although the regulation varies from product to product, the primary additions are related to documentation, with additional product information and traceability requirements.

Although the new regulation does not impact the functionality or risk profile of the products, medical device manufacturers’ compliance requirements are significant. As such, the entire industry is focusing on preparing for compliance.

This article gives you the critical facts about the regulations, and what medical device manufacturers should be doing to ensure they will be compliant.

What is addressed in the new requirements?

How are EU manufacturers preparing for compliance?

Preparing for compliance is not unique to the new EU regulations. To ensure compliance, manufacturers have a quality management system (QMS) in place where they can update product classifications and support clinical evaluation.

They have adopted paperless manufacturing with the implementation of MES, which automates the generation of the electronic device history records (eDHRs) and electronic batch records (eBRs).

In addition to supporting and containing product recalls stated above, an MES provides proactive enforcement to ensure the right procedures, operators, equipment and materials are used within specification and in the right sequence.

MES enables you to build in quality, preventing errors by enforcing as-designed production and reducing the risk of defective devices and recalls. Further, the MES automates labeling and packaging requirements and supports the QMS during production. The MES also supports post-market surveillance, returning critical performance data back to engineering to continuously improve quality.

Manufacturers trust Siemens as the manufacturing solutions leader in MD&D

Opcenter™ EX MD&D software, which is part of the Xcelerator™ portfolio, the comprehensive and integrated portfolio of software and services from Siemens Digital Industries Software, is a leader in MES for medical device manufacturing. Using Opcenter enables the user to proactively enforce the 5Ms of manufacturing – man, material, method, measure and machine – reducing human error and standardizing processes with e-procedures.

Using Opcenter creates end-to-end visibility throughout the production process. Because Opcenter facilitates the automation data capture throughout production, a natural byproduct of the MES is the eDHR and eBR. Incorporating nonconformance management into the production process, compliance management is streamlined. Opcenter functionality is regulation-validated. Based on the new EU MDR regulations, Opcenter is a leading solution to handle the changes related to product labeling and documentation.

Opcenter enables users to automatically print product and tracking labels from original specifications and real-time manufacturing data, making sure that labels are complete and accurate, are produced in a timely manner and are attached to the proper unit, lot or batch.

These capabilities provide significant benefits for MD&D manufacturers, including: | Americas: 1 800 498 5351| Europe: 00 800 70002222 | Asia-Pacific: 001 800 03061910 | For additional numbers, click here.