Notified Body Coordination: Compliance in MDD & MDR Processes

Notified Body Coordination "MDD&MDR"

Notified Body Coordination

In the medical device sector, strict regulations are implemented under the European Union's Medical Device Directive (MDD) and the more recent Medical Device Regulation (MDR) to ensure the safety and performance of products. In these processes, Notified Bodies undertake compliance assessment and certification tasks for medical device manufacturers to place their products on the market.

MDD and MDR: Key Differences

MDD (93/42/EEC)

• Date of Publication: 1993
• Focuses on the safety and performance of medical devices.
• It offers a more flexible framework and the clinical assessment requirements are relatively light.
• Risk classification is based on the type of medical devices.

MDR (2017/745)

• Publication Date: 2017
• Transition Process: Transition from MDD to MDR was completed in 2021.
• Includes more comprehensive and stringent regulations.
• Clinical Evaluation Requirements: Clinical data and post-market surveillance (PMS) have been significantly increased.
• Product Scope: Covers more product groups such as aesthetic devices and software.
• Unique Device Identification (UDI)System: Requires unique identification system for traceability of devices.

Role and Importance of Notified Bodies

Notified bodies provide support to manufacturers and conduct independent assessments for compliance with the MDD and MDR. Their tasks include the following:

• Technical File Review: Reviews technical documentation and conformity assessment reports of products.
• Risk Management Assessment: Assesses risk management processes in accordance with ISO 14971.
• Clinical Evaluation: Analyzes the safety and efficacy of the product based on clinical data.
• Audits: Audits manufacturing processes and quality management systems (e.g. ISO 13485).
• Certification: It issues a certificate of conformity for products to receive CE marking.

Obtaining your CE Marking

Finally, it is recommended to start the transition process as early as possible. Although the MDR transition has been delayed, waiting times to obtain CE markings are significant as Notified Body capacity is still a strong bottleneck in this process. In addition, significant changes and additional documentation may be required for your device which will require sufficient time for compilation and review.

Most manufacturers will need to take a hybrid approach to certifying their devices depending on the type and variety of devices they already have, new products launched, the quantity and quality of clinical evidence available and the internal resources available to certify devices.

Can Nanolab Help My Medical Device Achieve Biocompatibility?

Understanding and preparing to comply with these new regulations is critical. Nanolab experts will help you understand your testing needs, obtain certification and get your products safely to the patients who need them.

Contact us for more information.

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