A notified body is an organization designated by a country within certain regulatory frameworks, particularly within the European Union, to assess the conformity of certain products before they are marketed. These bodies have the authority to perform assessments and issue certifications, ensuring that a product meets specific safety, health, and environmental protection requirements. Notified bodies are crucial for products that require a high level of technical scrutiny, such as medical devices and construction products.
What is the difference between a notified body and a conformity assessment body?
A notified body and a conformity assessment body are both involved in the regulatory processes of certifying products, but they serve distinct roles primarily within different regulatory frameworks. A notified body, specific to the European Union, is an organization designated by an EU member state to assess the conformity of certain products before being placed on the market. These products typically fall under directives that require a higher level of scrutiny, such as medical devices or personal protective equipment. On the other hand, a conformity assessment body can operate globally and conduct activities to determine whether products, processes, services, or systems meet specified requirements. These bodies may handle a broader range of certifications beyond those mandated by specific regional regulations like the EU’s.
Examples of notified bodies
Notified bodies are organizations designated by EU member states to assess the conformity of certain products to meet the requirements of the European Union's directives and regulations before they can be sold within the EU. Here are examples of notified bodies that are commonly recognized for their roles in various sectors such as medical devices, construction products, and personal protective equipment:
- TÜV SÜD Product Service GmbH is a German company that offers regulatory compliance testing and certification services, particularly strong in the medical devices sector.
- BSI Group (British Standards Institution) is the UK's national standards body, providing certification services for a wide range of products, including medical devices and construction products.
- DEKRA Certification GmbH is a German company that provides inspection and certification services for various products, including automotive components and electrical equipment.
- SGS Fimko Oy is a Finnish company that is part of the SGS group known for its testing, inspection, and certification services across many sectors, including electronics and protective equipment.
- Intertek is a UK-based company that offers assurance, testing, inspection, and certification services across various industries, including textiles, toys, and electronics.
These notified bodies play a crucial role in ensuring that products meet the high standards set by EU regulations, focusing on safety, quality, and environmental protection.
What is a notified body in medical devices?
A notified body in the context of medical devices is an organization designated by an EU member state to assess whether certain types of medical devices meet the strict requirements of the European Union before they can be sold within the EU market. These bodies are responsible for conducting conformity assessments, including audits of quality management systems and technical documentation reviews. Their evaluation is essential for medical devices that fall under the higher risk categories as defined by EU regulations, such as implantable devices and certain diagnostic equipment. Successful assessment by a notified body results in the issuance of a CE mark, indicating regulatory compliance and allowing the device to be marketed in the EU.
How many Notified Bodies are in MDR?
As of the latest updates, there are over 20 notified bodies designated under the EU Medical Device Regulation (MDR) 2017/745. This number can fluctuate as new bodies are designated and existing ones possibly expand their scope or have their designations modified. These bodies are spread across various EU member states, providing necessary conformity assessment services to ensure that medical devices comply with the stringent requirements of the MDR before being placed on the European market.
