Preparing for the European Union Medical Device Regulation

The new European Union Medical Device Regulation (EU MDR) has come into effect, bringing significant changes to the production and distribution of medical devices in Europe.

We understand that these changes may raise concerns related to regulation, its timing in place, and what to do with products that are currently under old regulation. Therefore, we want to address these concerns while highlighting our regulatory expertise.

We want to share with you our top tips for what to be prepared for:

1. Stricter Regulations: the MDR introduces more stringent requirements for clinical evidence, post-market surveillance, and traceability of medical devices, raising the bar for quality and safety standards;

2. Authorities will now closely monitor medical devices throughout their lifecycle, with a central European database for better traceability and faster identification of unsafe products;

3. The MDR also covers previously unregulated devices, such as certain software and diagnostic devices, requiring compliance with regulatory requirements.

So, how to be prepared for the EU MDR?

But fear not. Here are some ways to get ready for these changes:

1. Assess your current processes, documentation, and product portfolio to ensure compliance with the new regulations;

2. Engage with notified bodies, industry experts, and stakeholders to stay informed about the latest regulatory updates and best practices;

3. Implement robust post-market surveillance systems to monitor the safety and performance of your devices, and promptly address any issues;

4. Invest in R&D: prioritise research and development efforts to meet the increased clinical evidence requirements and stay ahead of the competition;

5. Educate Your Team: provide comprehensive training to your employees on the new regulations, including their roles and responsibilities in ensuring compliance.

We believe that these changes are better for everyone. They will improve patient safety, enhance the quality of medical devices, and foster innovation in the industry.

Our commitment

At OFI we are committed to ensuring compliance with the MDR and delivering high-quality medical devices that meet the new regulatory requirements. 

We are proud to say that some of our medical devices are the first ones in Italy to be approved for the new MDR, while the rest of them are already in the process and will be approved soon following the technical times required by the notified body. 

Our medical devices are in the following areas: 

• Cough respiratory system;
• Oral care;
• Gastroesophageal area.

You can contact us for more information and the full medical devices list.

Let’s navigate this journey together and stay ahead of the changes! 

Feel free to reach out for any questions or concerns.