Medical devices sold in the European Union must undergo a conformity assessment by a Notified Body before receiving CE marking. MDR certification confirms that the device meets the safety, quality and performance requirements defined in EU Medical Device Regulation (EU) 2017/745.
The European Union Medical Device Regulation (EU MDR 2017/745) introduced significantly stricter requirements for manufacturers wanting to access the EU market. Compared with the previous Medical Device Directive (MDD), the EU MDR requirements demand more extensive technical documentation, stronger clinical evidence and increased scrutiny from a designated Notified Body.
As a Notified Body, we support manufacturers throughout their EU MDR certification journey – from regulatory strategy and conformity assessment to ongoing compliance. Our global network of auditors and technical experts helps you navigate the complex MDR landscape and achieve certification efficiently.
Discover the benefits of our MDR certification services
Gain access to the European market
Achieve CE marking under EU MDR 2017/745 and demonstrate MDR compliance with EU regulatory requirements.
Navigate complex regulatory requirements
Benefit from expert guidance on MDR classification rules, clinical evidence requirements and technical documentation expectations.
Streamline global certification strategies
Combine EU MDR certification with ISO 13485, UKCA and MDSAP services to support efficient multi-market access.
Prepare for stricter conformity assessments
Work with experienced auditors and technical experts familiar with the increased regulatory scrutiny under MDR.
Plan your MDD to MDR transition
Understand the regulatory timelines and requirements associated with the MDR transition.
Transfer existing EU MDR certificates
Transfer eligible MDR certificates to SGS under MDR Article 58 without restarting your certification cycle.
Why SGS?
We are the world’s leading testing, inspection and certification company and are recognized as the global benchmark for quality and integrity. EU Medical Device Regulation (EU MDR 2017/745) is complex and applies to multiple device classes, including Class IIa, Class IIb (implantable and non-implantable) and Class III devices. Our specialists provide the regulatory expertise and technical knowledge required to help you navigate MDR requirements and achieve certification efficiently.
We also support manufacturers through a range of complementary services designed to streamline certification and strengthen regulatory readiness, including:
- MDR Training courses to help your teams understand the new requirements
- Integrated or combined audit solutions to reduce duplication and save time and cost
- Assessments for specific EU MDR requirements such as Article 16 (medical device distributor) and Article 117 (drug-device combination assessment of the medical device component
- An account manager to guide you through your MDR certification project from application through approval
- Global resources with strong local presence – our teams understand regional markets while supporting global certification strategies
Our credentials
We are recognized by regulators and international programs as a trusted conformity assessment partner. Our credentials include:
- Notified Body in Belgium (NB 1639) for the EU MDR and In Vitro Diagnostic Regulation (IVDR)
- UK Approved Body (AB 0120) for the UKCA mark
- Approved Auditing Organization (AO) for the Medical Device Single Audit Program (MDSAP)
- An accredited ISO 13485 (medical devices – quality management systems) Certification Body
FAQ
A Notified Body is an independent organization designated by an EU member state to assess medical device conformity. Notified Bodies review technical documentation, conduct audits and issue certification confirming compliance with MDR requirements.
Compared with the Medical Device Directive, MDR introduces:
- Broader scope and updated MDR device classification rules
- Stronger MDR clinical evaluation requirements
- Unique device identification (UDI) requirements
- Improved traceability through the EUDAMED database
- Expanded post-market surveillance obligations
- Reinforced regulatory responsibilities for manufacturers
The EU MDR changes increase regulatory scrutiny and require more comprehensive technical documentation.
Preparing for your MDR certification requires careful planning, documentation and coordination with your Notified Body.
| Steps | EU Resources | SGS Resources |
|---|---|---|
| Determine if your products fall under the scope of the EU MDR, determine classification, formulate EU regulatory strategy. | 2017/745 EU MDR MDCG guidelines | Read our guide: Watch our video: [Provide links] Explore our SGS Academy MDR |
| Understand the SGS MDR certification process. | Read our guide on the Medical Device Regulation (MDR) (EU) 2017/745 Certification Process | |
| Update your QMS and product technical documentation | Read our white paper: Standards for EU Medical Device Regulatory Compliance | |
| Apply for the conformity assessment. | Read our article: When should you call the NB/CB/AO relative to initial/changed product/system maturity state? Apply via the SGS MDR Information Center |
Yes. When applicable, artificial intelligence (AI) requirements under the EU Artificial Intelligence Act can be assessed as part of the EU MDR conformity assessment by qualified auditors and product assessors. Successful MDR certification confirms that the AI-enabled device meets the relevant regulatory requirements.
Yes. Eligible MDR certificates can be transferred to SGS under MDR Article 58 during your certification cycle, allowing you to continue certification with SGS without restarting the process. Read more about the transfer process for qualified certifications.
To keep marketing medical device products in the EU, manufacturers with a valid MDD certification must transition to the MDR. The timeline for the MDD to MDR transition has been extended by MDR Amendment 2023/607. Watch our webinar, Understanding the MDD Validity Extension Process per MDR Amendment 2023/607, for more information.