Europe Regulatory ServicesA Notified Body is an independent third-party conformity assessment organization designated by a European Union Member State to evaluate whether medical devices and in vitro diagnostic medical devices comply with the requirements of EU MDR 2017/745 and IVDR 2017/746. Acting as a regulatory gatekeeper, Notified Bodies assess a manufacturer’s Quality Management System (QMS), Technical Documentation, clinical or performance evidence, and regulatory processes before issuing the certificates required for CE marking.
Notified Bodies are designated for specific device technologies and regulatory scopes. Therefore, manufacturers must ensure that the selected Notified Body is authorized to assess their particular device type and classification.
Our Services Include
- NANDO Database Assessment to verify Notified Body designation and regulatory capabilities.
- Notified Body Identification and Selection based on device classification and designation scope.
- MDR/IVDR Scope Verification for applicable device categories and technologies.
- Notified Body Application Preparation and Submission Support.
- Regulatory Communication and Coordination with Notified Bodies throughout the assessment process.
- MDR Code Assignment Support in accordance with MDCG 2019-14 and applicable designation requirements.
- MDA/MDN Code Identification based on device type, design, and intended purpose.
- MDS Code Assessment for applicable device characteristics.
- MDT Code Assessment for relevant manufacturing technologies and processes.
- Conformity Assessment Planning and regulatory documentation support.
What Does a Notified Body Do?
A Notified Body performs independent conformity assessments to verify that a device meets the applicable regulatory requirements before it can be placed on the European market. Depending on the device classification and conformity assessment route, their activities may include:
- Technical Documentation Review
- Quality Management System (QMS) Audits
- Clinical Evaluation and Performance Evaluation Assessment
- Risk Management Review
- Verification of GSPR Compliance
- Product Testing and Inspection
- Assessment of Post-Market Surveillance Processes
- Surveillance and Recertification Audits
Following successful assessment, the Notified Body issues the relevant certificates supporting CE marking and market access within the European Union.
When is a Notified Body Required?
Medical Devices (MDR)
Notified Body involvement is generally required for:
- Class Is (Sterile Devices)
- Class Im (Devices with a Measuring Function)
- Class Ir (Reusable Surgical Instruments)
- Class IIa Devices
- Class IIb Devices
- Class III Devices
Most Class I devices may be self-certified by the manufacturer.
In Vitro Diagnostic Medical Devices (IVDR)
Notified Body involvement is generally required for:
- Class B Devices
- Class C Devices
- Class D Devices
Most Class A IVDs can be self-declared by the manufacturer unless sterility-related requirements apply.
Selecting the Right Notified Body
Selecting an appropriate Notified Body is a critical step in the certification process. Manufacturers should consider:
- MDR and/or IVDR Designation Scope
- Device Technology Expertise
- Assessment Timelines and Capacity
- Geographic Coverage
- Experience with Similar Device Types
- Audit and Surveillance Capabilities
- Communication and Regulatory Support
Early engagement with a suitable Notified Body can help streamline certification activities and reduce regulatory delays.
NANDO - New Approach Notified and Designated Organizations
NANDO (New Approach Notified and Designated Organisations) is the official European Commission database that provides a comprehensive list of Notified Bodies designated under EU MDR 2017/745 and IVDR 2017/746. The database enables manufacturers to identify and verify Notified Bodies based on their designation scope, technical expertise, device categories, conformity assessment capabilities, and applicable regulatory framework.
Requirements for Notified Bodies
The requirements for Notified Bodies are defined in Annex VII of EU MDR 2017/745 and IVDR 2017/746.
- Organizational Requirements: Notified Bodies must maintain independence, impartiality, confidentiality, and freedom from conflicts of interest.
- Quality Management System Requirements: Notified Bodies are required to maintain a robust Quality Management System that includes:
- Document and Record Control
- Internal Audits
- Management Review
- Personnel Competency Management
- Continuous Improvement Processes
- Resource Requirements
Notified Bodies must possess sufficient personnel, expertise, and infrastructure to perform conformity assessments within their designated scope.
- Process Requirements: Documented procedures must be established for:
- Application Review
- Technical Documentation Assessment
- Audit Activities
- Certification Decision-Making
- Surveillance Audits
- Recertification Activities
- Management of Non-Conformities
Assignment of MDR codes - MDCG 2019-14
Codes for Notified Bodies under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) are primarily used by designating authorities to define the scope of designation. These codes also serve to identify the qualifications of Notified Body personnel and the expertise required to assess specific medical devices. These codes are used to:
- describe the individual qualification of the NBs staff members
- describe the qualification required for assessing a device
Assignment of codes to devices within the conformity assessment procedure
The designation codes under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) should be applied using a multidimensional approach that considers the different types, characteristics, technologies, and manufacturing processes associated with medical devices. This approach ensures that Notified Bodies (NBs) and their assigned personnel possess the appropriate qualifications, technical competence, and expertise to perform conformity assessments effectively.
When submitting an application to a Notified Body, the manufacturer must identify the types of devices and relevant technologies for which conformity assessment is requested. During the application review stage, as specified in Section 4.3 of Annex VII of the MDR, the Notified Body verifies the codes proposed by the manufacturer or determines the applicable codes independently. This review establishes whether the requested devices fall within the NB's designated scope and whether adequate resources and competent personnel are available to conduct the required conformity assessment activities.
The final assignment of codes is determined by the Notified Body. Following the application review and contract finalisation, the NB allocates appropriately qualified and authorised personnel to undertake the relevant technical documentation reviews, product assessments, and audit activities.
The following table summarises the different categories of designation codes, their application to medical devices:
| Code Type | Assignment to Device |
|---|---|
| MDA/MDN - Codes defining device design and intended purpose. | Assign exactly one code per device, selecting the highest applicable code according to the hierarchy in Regulation (EU) 2017/2185. |
| MDS - Horizontal codes defining specific device characteristics. | Assign all applicable codes after MDA/MDN code assignment. |
| MDT - Horizontal codes defining technologies and manufacturing processes. | Assign one or more applicable codes describing the principal manufacturing technologies and processes, after MDA/MDN code assignment. |
We assist medical device and IVD manufacturers in identifying suitable Notified Bodies and determining applicable designation codes to support conformity assessment under EU MDR 2017/745 and IVDR 2017/746.
