The medical device industry is vast, diverse, and heavily regulated, with different countries and regions having varying regulatory requirements and processes. The European Union (EU) is one of the largest markets in the world for medical devices, and if you intend to put a medical device on the market in the EU, there is a good chance you’ll have to work with a Notified Body.
So, what is a Notified Body? In this brief blog post, we’ll discuss what Notified Bodies are, what they do, and how to work with one.
Notified Bodies play the role of gatekeepers to the EU market for a majority of medical devices/in vitro diagnostics. Notified Bodies for medical devices are independent organizations appointed by EU member states to assess the conformity of certain products before they are placed on the market. Conformity assessments ensure that products are technically safe, compliant, correctly documented, and manufactured under the correct conditions as outlined by applicable legislation, primarily the EU MDR and IVDR in the case of medical devices.
It’s important to note that not all Notified Bodies have the capability to perform assessments for all types of products. For instance, some Notified Bodies have been designated for MDR, meaning they can perform conformity assessments according to EU MDR 2017/745, Article 35, and others can provide conformity assessments for in vitro diagnostics (IVDs) in accordance with EU IVDR 2017/746, Article 32. It’s essential to make sure you work with the right Notified Body to get your medical device to the EU marketplace.
Medical devices regulated under the MDR as Class IIa, Class IIb, or Class III devices require that a conformity assessment be performed by an accredited Notified Body before receiving a CE marking and being placed in the market. Some Class I devices also require an assessment by a Notified Body, including devices that are sterilized, have a measuring function, or are reusable surgical instruments. Other Class I devices can be self-assessed by the manufacturer.
In vitro diagnostic (IVD) devices designated as Class B, Class C, or Class D also require a conformity assessment by a Notified Body. Only Class A IVDs can be self-assessed by the manufacturer.
All medical devices must have CE marking before they can enter the European market. One of the main roles of Notified Bodies is to provide conformity assessment on medical devices before granting them a CE marking, which is also known as a “European Passport,” as it allows products to move relatively freely throughout the EU.
Notified Bodies provide conformity assessment during both the design and production phases of a product, ensuring that medical device manufacturers live up to the requirements of the MDR/IVDR. They audit manufacturing processes and conditions, quality management systems (QMS), and product specifications to make sure that they conform with EU regulations before being placed on the market. It’s also the role of the Notified Body to make sure the manufacturer has the infrastructure in place to market and provide post-market surveillance in the EU.
Notified Bodies provide conformity assessment in support of the EU MDR/IVDR General Safety and Performance Requirements (GSPR) but ultimately, it’s the manufacturer’s responsibility to ensure all requirements have been fulfilled. This includes choosing the right Notified Body to work with to get their medical device on the EU market.
It might surprise you to know that not all Notified Bodies are designated for both MDR and IVDR, meaning that it is critical that you do your due diligence to connect with the right Notified Body for your product. Notified Bodies are designated by the competent authority of EU member states to perform certain types of conformity assessments for certain types of medical devices and manufacturing processes/conditions. This means that the Notified Body you work with is largely dependent on the type and classification of your medical device as well as the type of conformity assessment process you want the Notified Body to perform. A list of accredited Notified Bodies is available in the EU NANDO database, which can be searched and filtered by country, specific legislation, and other technical competencies.
A lot rides on selecting the right Notified Body, so it’s imperative that you find the organization that best fits your company’s needs. Learn what you can about their processes, how they communicate with their clients, and even their submission templates and processes. Choose an organization whose standards and processes align with your company’s goals.
According to Rimsys regulatory expert, Bruce McKean, when it comes to working with a Notified Body, “You can benefit from building a relationship with your Notified Body and collaborating with them on various topics. Although MDR and IVDR have forced more stringent requirements that may hinder a consulting relationship, they’re usually willing to offer a certain level of guidance to help you.”
Choosing and working with an Notified Body is a critical step towards getting your product on the EU market, especially for new medical devices. Be sure to do your research before selecting an Notified Body, and communicate with them throughout the product realization phases to ensure your medical device is in compliance with MDR/IVDR requirements. Working successfully with a Notified Body is the best way to fast-track your medical device into one of the largest markets in the world.
Read more about the general safety and performance requirements (GSPR) that Notified Bodies use as the basis for conformity assessments.