What Is A Notified Body & Key Differences With Other Conformity Assessment Bodies
Written by Claudia Rose-Mastrobuoni – Quality & Regulatory Manager
What is a notified body?
A notified body is an independent organization designated by a European Union (EU) Member State to assess whether certain regulated products, most notably medical devices and in vitro diagnostic devices (IVDs), comply with applicable EU legislation before they are placed on the EU market.
For manufacturers based in the United States, understanding what a notified body is is essential when exporting products to Europe. Unlike the US regulatory system, where the Food and Drug Administration (FDA) directly oversees market authorization for medical devices, many EU conformity assessments are carried out by notified bodies acting as independent third parties under EU law.
Notified bodies operate under the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Regulation (EU IVDR 2017/746) and play a central role in enabling CE marking for most medium and high-risk devices.
Contents
- Why notified bodies matter for US and global manufacturers
- What does a notified body do?
- Which products require a notified body?
- How notified bodies are designated and monitored
- How notified bodies support CE marking
- Approved bodies in the United Kingdom
- Certification bodies and Accreditation bodies
- Summary: What is a notified body
- How Apotech can help
- Notified body FAQs
Why notified bodies matter for US and global manufacturers
The EU regulatory framework relies on a third-party conformity assessment model for many regulated products. In this model:
- Notified bodies assess conformity with EU regulatory requirements
- Manufacturers use these assessments to support CE marking
- CE marking allows products to be placed on the EU market and circulated within the European Economic Area
For US manufacturers, engagement with a notified body is often one of the most significant regulatory steps when entering the European market. Availability, scope of designation, and review timelines can all directly affect development and commercialization plans.
What does a notified body do?
A notified body evaluates whether a manufacturer and its products meet applicable EU regulatory requirements. The scope and depth of assessment depend on the device classification and the selected conformity assessment route.
Typical notified body activities include:
- Auditing the manufacturer’s quality management system (QMS)
- Reviewing technical documentation against MDR or IVDR requirements
- Assessing clinical evidence, including the clinical evaluation report (CER), where applicable
- Verifying compliance with general safety and performance requirements (GSPRs)
- Issuing EU conformity certificates that enable CE marking
- Conducting ongoing surveillance, including periodic audits and documentation reviews
While the notified body issues the conformity certificate, the manufacturer remains fully responsible for regulatory compliance throughout the product lifecycle.
Which products require a notified body?
Not all products require assessment by a notified body. Whether notified body involvement is required is determined by EU legislation and product risk classification.
For medical devices regulated under EU MDR:
- Higher-risk devices, such as Class IIa, Class IIb, and Class III, require notified body involvement
- Class I devices are generally self-certified, except where the device is:
- Sterile
- A reusable surgical instrument
- A device with a measuring function
For IVDs regulated under EU IVDR, notified body involvement is required for most device classes.
Under Article 36 of the EU MDR, notified bodies must maintain sufficient administrative, technical, scientific, and clinical expertise and must make documentation available to their designating authorities for oversight and surveillance activities.
How notified bodies are designated and monitored
Notified bodies are designated by competent authorities within EU Member States following a rigorous assessment of:
- Technical competence and sector expertise
- Organizational structure and independence
- Quality management systems
- Impartiality and conflict-of-interest controls
Once designated, notified bodies are formally notified to the European Commission and listed in the NANDO (New Approach Notified and Designated Organisations) database. This database allows manufacturers to confirm whether a notified body is authorized to assess specific product types and regulations.
Designation is subject to ongoing monitoring, reassessment, and peer review at both national and EU levels.
How notified bodies support CE marking
The CE mark indicates that a product complies with all applicable EU regulatory requirements. When notified body involvement is required, manufacturers cannot self-declare conformity.
The process typically involves:
- Preparing technical documentation and quality evidence
- Undergoing conformity assessment by a notified body
- Receiving a conformity certificate if requirements are met
- Issuing a declaration of conformity and affixing the CE mark
This process provides regulators, healthcare professionals, and patients with assurance that products meet defined safety and performance standards.
Approved bodies in the United Kingdom
In the United Kingdom, conformity assessment is performed by approved bodies rather than notified bodies. Approved bodies are designated by the Medicines and Healthcare products Regulatory Agency (MHRA) under the UK Medical Devices Regulations 2002 (UK MDR 2002).
Approved bodies assess:
- Active implantable medical devices
- Medical devices
- In vitro diagnostic devices
Successful assessment allows products to bear the UKCA mark and be placed on the market in England, Wales, and Scotland.
Key considerations for global manufacturers
- Manufacturers may apply to any UK approved body within the relevant scope
- The assessment route depends on device classification and regulatory pathway
- Approved bodies are designated for a maximum of five years and are subject to MHRA oversight
Devices placed on the Northern Ireland market continue to require CE marking, meaning manufacturers must engage an EU-recognized notified body or a UK body designated for the UKNI route.
Certification bodies and Accreditation bodies
Certification bodies
Certification bodies assess whether products, systems, or processes comply with specific standards such as ISO 13485:2016. Their role typically includes audits and technical reviews.
Certification supports quality and compliance objectives but does not grant regulatory market access unless explicitly required by law.
Examples include BSI Group, TÜV SÜD, SGS, UL Solutions, Intertek, and DEKRA.
Accreditation bodies
Accreditation bodies evaluate and formally recognize the competence and impartiality of certification bodies and testing laboratories. They operate at a system level to ensure certification activities are reliable and aligned with international standards.
Examples include: UKAS, ANAB, DAkkS, NATA, and INMETRO.
Certification and accreditation are related but distinct functions within global quality and regulatory systems.
Summary: What is a notified body
A notified body is a designated third-party organization responsible for assessing the conformity of regulated products under EU legislation. For US manufacturers seeking access to the European market, notified bodies are a critical part of the regulatory pathway to CE marking.
Approved bodies perform a similar function in the UK, while certification and accreditation bodies support broader quality system assurance across global markets.
How Apotech can help
Apotech supports US and global manufacturers in working effectively with notified bodies, approved bodies, and certification bodies. Our teams help clients prepare for conformity assessments, strengthen technical documentation, and maintain inspection readiness across jurisdictions.
If you would like support with CE marking, EU MDR audits, or any other related regulatory consultancy, our teams can help you prepare for and navigate notified body assessments with confidence.
Notified body FAQs
A notified body is an independent organization designated by an EU Member State to assess whether certain regulated products comply with EU regulatory requirements before being placed on the market.
A notified body performs regulatory conformity assessments required by EU law and can issue certificates for CE marking. A certified body, more accurately called a certification body, assesses compliance with standards such as ISO 13485 and does not grant regulatory market access.
The role of a notified body is to independently assess product conformity, including reviewing technical documentation, auditing quality systems, and issuing conformity certificates where required.
Notified bodies are designated and overseen by the competent authority in the EU Member State that appointed them and are monitored at EU level by the European Commission.
Notified Bodies are required under Article 50 MDR to publish public “standard fee lists” covering application fees, audits, documentation review, and annual surveillance. The majority of them also provide specific guidance on their websites, for example, see here for the Medical Device Coordination Group Document MDCG 2023-2.
Regulators urge manufacturers to engage early with Notified Bodies due to bottlenecks and capacity limits under MDR. Real-world timelines typically span 12-18 months, depending on clinical evidence needs.