What Is a Notified Body?
A notified body is an independent organization designated by a national authority within the European Union (EU) or European Economic Area (EEA) to assess the conformity of certain products before they are placed on the market. These entities play a crucial role in Regulatory Compliance and Product Certification, ensuring that goods meet the essential health, safety, and environmental standards set out in EU directives and regulations. Notified bodies perform various conformity assessment procedures, including inspecting products, reviewing technical documentation, and auditing manufacturers' quality management systems, to ensure products comply with applicable legislation before receiving the mandatory CE marking.
History and Origin
The concept of notified bodies emerged as part of the European Union's "New Approach" to technical harmonization and standards, initiated with a Council Resolution on May 7, 1985. This "New Approach" sought to remove technical barriers to international trade within the European single market by limiting legislative harmonization to essential safety requirements and entrusting the development of detailed technical specifications to European standardization organizations. This framework shifted the emphasis from prescriptive national regulations to performance-based EU directives, which in turn necessitated independent third-party assessment for certain high-risk products. Notified bodies became the designated entities responsible for verifying compliance with these new directives, enabling products to move freely across European Union member states.6
Key Takeaways
- A notified body is an independent organization authorized to assess product conformity with EU regulations.
- Their primary function is to verify that products meet essential health, safety, and environmental requirements before market entry.
- Notified bodies are integral to the CE marking process, which indicates a product's compliance with EU directives.
- They conduct various assessments, including document reviews, product testing, and auditing of manufacturers' quality control systems.
- Manufacturers must engage a notified body for certain product categories, especially those with higher inherent risks, before placing them on the EU/EEA market.
Interpreting the Notified Body
A notified body's assessment signifies that a product, its design, and its manufacturing process conform to specified EU regulation or directive. The involvement of a notified body provides a crucial layer of independent verification, assuring market surveillance authorities and consumers that the product meets stringent EU requirements. When a product bears the CE mark alongside the four-digit identification number of a notified body, it indicates that the notified body has been involved in the certification process, typically for higher-risk products where self-declaration of conformity by the manufacturer is not sufficient. Manufacturers are free to choose any legally designated notified body to carry out their conformity assessment procedure.5
Hypothetical Example
Consider "MediTech Innovations," a company based outside the EU that manufactures a new type of implantable medical device. To sell this device in the European market, MediTech Innovations must obtain CE marking. Since implantable medical devices fall under a high-risk category, self-declaration of conformity is not permitted. MediTech Innovations would need to engage a notified body, such as "EuroCert GmbH," an organization designated by Germany, to perform a conformity assessment.
EuroCert GmbH would review MediTech's technical documentation, including design specifications, risk analyses, and clinical data. They would also conduct an audit of MediTech's manufacturing facilities and quality control systems to ensure ongoing compliance with relevant standards. If EuroCert GmbH determines that the device and MediTech's processes meet all the essential requirements of the EU Medical Device Regulation (MDR), they would issue a CE certificate. This certificate, along with the CE mark and EuroCert's unique identification number on the product, allows MediTech to legally place its device on the EU market.
Practical Applications
Notified bodies are essential gatekeepers across various industries regulated by the European Union. Their services are particularly critical for sectors where product failure could lead to significant harm, such as:
- Medical Devices: From syringes to complex surgical implants and in-vitro diagnostics, notified bodies assess devices for compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
- Construction Products: Ensuring the safety and performance characteristics of building materials.
- Machinery: Verifying that industrial and consumer machinery meets safety directives.
- Personal Protective Equipment (PPE): Certifying items like safety helmets, high-visibility clothing, and respirators.
- Pressure Equipment: Assessing equipment such as pressure vessels and boilers.
These bodies ensure that products entering the EU market adhere to strict product safety standards, contributing to consumer protection and fair competition. Their tasks include evaluating due diligence processes, conducting unannounced audits, and issuing necessary certificates for market entry.4 Notified bodies operate as independent, accredited bodies entitled by an authorized accreditation body.3
Limitations and Criticisms
Despite their vital role, the notified body system has faced criticisms and limitations. A primary concern revolves around capacity issues, particularly with the introduction of new, more stringent regulations like the EU Medical Device Regulation (MDR). Many manufacturers have experienced significant delays in obtaining certification due to an overwhelmed system, potentially leading to products being removed from the EU market.2 Another challenge involves the consistency of assessments across different notified bodies, with some critiques pointing to varying interpretations of regulations or different levels of expertise, which could potentially lead to "forum shopping" by manufacturers seeking less rigorous scrutiny. Furthermore, the commercial relationship between manufacturers and notified bodies can sometimes raise questions about the impartiality of the risk management and certification process.
Notified Body vs. Accreditation Body
While often discussed in the same breath, a notified body and an accreditation body serve distinct but complementary functions within regulatory frameworks.
A notified body is an organization designated to perform conformity assessments on specific products as required by EU directives or regulations. Its role is to verify that a manufacturer's product meets the essential requirements to bear the CE mark and be sold in the EU/EEA. They issue certificates of conformity.
An accreditation body, on the other hand, is a national authority that assesses and formally recognizes the competence and impartiality of conformity assessment bodies, including notified bodies. It establishes the criteria and conducts regular evaluations to ensure that notified bodies possess the necessary technical expertise, resources, and independence to perform their tasks reliably. Essentially, the accreditation body accredits the notified body, which then certifies the product. The accreditation body acts as a supervisor of the notified body, ensuring the integrity and credibility of the entire product certification system.
FAQs
What is the primary purpose of a notified body?
The primary purpose of a notified body is to independently assess and verify that specific products, particularly those with higher risks, comply with the essential health, safety, and environmental requirements outlined in EU directives and regulations before they can be sold in the European market. This assessment is crucial for products to receive CE marking.
How does a company choose a notified body?
Companies seeking CE marking for their products can choose any notified body that is legally designated for the specific product directive or regulation relevant to their product. Factors in selection often include the notified body's expertise in the specific product type, its responsiveness, location, and service fees. The European Commission maintains a public database (NANDO) listing all designated notified bodies and their scopes.1
Are notified bodies government entities?
While notified bodies are designated and supervised by national authorities of EU/EEA member states, they are typically independent private organizations. They must operate in a non-discriminatory, transparent, and impartial manner, adhering to strict criteria regarding competence and independence.
What is CE marking and its relationship to a notified body?
CE marking is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). It indicates that the product complies with EU legislation. For certain product categories, especially those with higher risks, the CE mark must be affixed after a notified body has conducted a conformity assessment and issued a certificate. When a notified body is involved, its unique four-digit identification number must appear next to the CE mark.