Extension to Scope of MDR Sterilization Services

We are excited to receive approval to extend the scope of our EU Medical Device Regulation (MDR) sterilization services.

The Federal Agency for Medicines and Health Products (FAMHP) has accepted our sterilization scope extension after verifying our training, qualification and in-house competence. We can now assess the following processes:

• Dry heat, as per EN 20857
• Vaporized hydrogen peroxide, as per ISO 22441
• Low-temperature steam and formaldehyde, as per EN ISO 25242
• Chlorine dioxide, as per EN ISO 14937
• Nitrogen dioxide, as per EN ISO 14937
• Supercritical carbon dioxide, as per EN ISO 14937

Our MDR designation scope has been updated accordingly and can be found on the European Commission website here.

Virginie Siloret, Global Medical Devices Certification Manager at SGS, welcomed the news: “Thanks to this scope extension, we can now serve customers that use these sterilization processes, including those utilizing very recent technology like supercritical carbon dioxide. We look forward to supporting you to evolve your sterilization methods, to benefit your business and the environment.”

Partnering with you to help you get ahead

We enable you to adapt effectively, showcasing your products' dependability and setting you apart in the competitive landscape. We are:

• An EU medical device Notified Body (NB), with NB status in Belgium (NB 1639) and Finland (NB 0598)
• A UK Approved Body
• An accredited ISO 13485 (medical devices – quality management systems) Certification Body
• A recognized Medical Device Single Audit Program (MDSAP) Auditing Organization

Our specialists worldwide will help you to:

• Ensure product quality and consistency
• Streamline production and service processes
• Effectively manage risks with proven compliance strategies
• Save time, money and resources
• Expand market reach and access new opportunities
• Stay ahead in the ever-evolving regulatory climate
• Combat counterfeit products and enhance supply chain traceability
• Elevate patient safety and treatment outcomes

Multifaceted medical device services

Our portfolio of services includes:

• ISO 13485 certification and training
• MDR and UKCA services for dental medical devices
• MDR and UKCA services for orthopedic medical devices
• MDR Article 117 assessment
• MDR certification services
• MDSAP services
• Medical device supply chain services
• Software as a medical device (SaMD) certification
• UKCA services for medical devices and in vitro diagnostic (IVD) medical devices
• Vascular device certification

We also have a comprehensive training?portfolio, covering MDR, IVDs, ISO 13485 and more.

Contact us to start or enhance your medical device compliance journey.

About SGS

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.