Frequency Of Notified Body Reassessments Increases: Why the European Commission Amends Existing Regulations

“Frequency Of Notified Body Reassessments Increases: the European Commission Amends Existing Regulations“, what is this about?

What are “Notified Body reassessments?

A Notified Body is an independent third-party organization that is designated by a Member State of the European Union to assess the conformity of certain products with the relevant EU legislation. The competent authority that designates an organization as a “Notified Body”, also frequently reviews and evaluates the performance. Therefore, the Notified Body is subject to regular assessments to ensure that it continues to meet the requirements set out in the EU legislation.

Competency assessment

During a reassessment, the Notified Body’s technical expertise, its resources, the quality management system, and compliance with the applicable regulations and standards are reviewed. If the Notified Body does not meet the requirements or standards, the qualified authority may take measures to restrict or withdraw the Notified Body’s designation.

A reassessment can impact the validity of certificates issued by the Notified Body and may require affected manufacturers to seek certification from another Notified Body.

What is the effect of this amendment?

On December 16, 2020, the European Commission (EC) published a proposal to amend Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices regarding the frequency of full reassessments of notified bodies.

What is current in March 2023?

The commission delegated regulation (EU) 2023/502, of December 1, 2022 states that full Notified Body reassessments already started before March 11, 2023, will continue in most cases. There is one exception to this. That is when the responsible authority of the Member State where the Notified Body is located suspends or terminates the ongoing full reassessment. Several factors may prompt this decision. Before suspending or terminating an ongoing full reassessment, the authority responsible for Notified Bodies hears the organization concerned.

For what reason is this measure taken?

The frequency of full reassessments of Notified Bodies will increase from every five to every three years. This is to ensure that notified bodies continue to meet regulatory requirements and maintain their competence in medical device assessment.

Unannounced audits

The amendment also sets out provisions for more frequent unannounced audits of Notified Bodies to improve the quality of their assessments and increase confidence in the safety and performance of medical devices.

From what date do the changes apply?

The European Parliament and the Council of the European Union adopted the proposal on May 26, 2021, and will apply from May 26, 2023. This means that notified body reassessments will occur more frequently from that date. The higher frequency of reassessments is just one of the measures the EC is taking to strengthen the regulatory framework for medical devices and improve patient safety.

NANDO database

The Frequency Of Notified Body Reassessments Increases. This picture shows a logo of the NANDO database which contains information about the organization's areas of expertise, their contact details, and the specific products or product categories they are authorized to assess.
Nando (New Approach Notified and Designated Organisations) Information System

The NANDO database is used to identify organizations that are authorized to carry out conformity assessment procedures on behalf of manufacturers seeking to comply with the New Approach. The database contains information about the organization’s areas of expertise, their contact details, and the specific products or product categories they are authorized to assess.

The term “NANDO” refers to the “New Approach Notified and Designated Organisations” database, which is a database managed by the European Commission that contains information about organizations that are designated or notified under the “New Approach” legislation.

The New Approach is a set of principles and rules that apply to the marketing of products in the European Union (EU). Under the New Approach, products are subject to certain essential requirements, such as health and safety standards, but manufacturers have flexibility in how they meet those requirements. Overall, the NANDO database plays an important role in ensuring that products sold in the EU meet high standards of safety and quality.