The EU MDR 2017/745 came into effect in May 2021. All medical devices certified under the previous Medical Device Directive (MDD) must certify to the new requirements to ensure that they can continue to be sold in the European market. Our MDR certification services provide a one-stop solution for all your medical device certification needs.
Why choose MDR certification services from SGS?
We can help you to:
- Understand the requirements through our internationally recognized training courses
- Confirm your products meet MDR requirements
- Acquire up-to-date MDR certification
- Gain the CE mark for your medical devices to ensure EU market access
We can ensure that medical devices certified under the MDD transition smoothly to the latest MDR certification requirements, which now cover:
- Broader scope and up-classification rules
- Tougher clinical evaluation
- Improved EUDAMED database to enhance traceability and transparency
- New unique device identifiers (UDIs)
- Stronger post-market surveillance
- Reinforced regulatory requirements
- Regulatory compliance responsibilities at the organization level
- Extended scope on products with no medical purpose but that are equivalent to devices with a medical purpose
Certification can take between 12 and 18 months, and in some cases longer.
Why SGS?
We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.
The requirements imposed by EU MDR compliance are complex and apply to multiple device types, including Class IIa, Class IIb (implantable and non-implantable) and Class III devices. We provide the unrivaled expertise in MDR requirements you need for a smooth certification process.
We are:
- A Notified Body in Belgium (1639)
- A Notified Body in Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD)
- An Approved Body for the UKCA mark (AB0120)
- An Approved Auditing Organization (AO) for MDSAP
We provide:
- Training courses to help you understand the new requirements
- Integrated and/or combined audit solutions to help you save time and money
- Assessment and certification services for specific MDR requirements, such as MDR Article 16 (Medical device distributor) and MDR Article 117 (drug-device combination, assessment of the medical device part)
- A dedicated account management team to ensure that your certification project gets the relevant support
- Global resources and a local presence – our people speak the language, understand the local market culture and operate globally