Notified Body Services

Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They help the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities. A key aspect of their role is to inspect the technical documentations of MDD Is/Im, IIa and IIb as well as review and approve Design Dossiers (for Class III devices) towards granting CE Certificates or EC Design Dossier Certificates. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website). However, as selecting a Notified Body device can be a complex process, it is also advised that an external expert supports this critical decision.

Definition

A European organization accredited/notified by an EU Member State Competent Authority with the aim to support the manufacturer with conformity assessment procedures & conformity certificates.

The Minimum Criteria to be met when designating Notified Bodies state that:

  • The NB shall not be the designer, manufacturer, supplier or installer of devices which they control, nor the authorized representative.
  • The NB shall possess the highest degree of professional integrity and technical competence and free of inducements.
  • The NB must have at its disposal the necessary staff and possess the necessary facilities & equipment.
  • The NB must have liability insurance.
  • The NB must practice professional secrecy.

 

Role of the Notified Body

Notified Bodies are designated by EU Authorities to assist the manufacturer and ensure they only bring safe and compliant products to the EU Market. Their duties include:

  1. Inspecting technical documentation.
  2. Carrying out conformity assessments.
  3. Issuing conformity certificates.
  4. Performing surveillance audits.

According to the Medical Device Directive, inspection by an accredited EU Notified Body will be required in the following instances:

  • MDDIs/ImIIa and IIb and Self-Test IVD – the manufacturer must submit a full Technical File for review and approval by the Notified Body, and obtain a CE Certificate from the Notified Body before being able to place the CE marking on the device.
  • Forall AIMDClass III MDD and IVD Annex II List A & B devices, the manufacturer must submit a full Design Dossier for review and approval by the Notified Body, as well as obtain an EC-Design Examination Certificate from the Notified Body before being able to place the CE marking on the device.
  • There is no legal requirement for Notified Bodies to review technical documentation of MDD Class I(non-sterile and with no measuring function) and IVD ‘All Others’.

 

Select a Notified Body

The European Commission provides a complete directory of Notified Bodies accredited for CE marking of medical devices. The Notified Body directory can be found on the NANDO website and lists over 60 Notified Bodies from 22 countries (including Turkey and Australia).

Manufacturers can refer to a Notified Body of their choice.

 

Obelis Notified Body Selection Services

Our Notified Body Selection services include:

  • Device Classification.
  • Identification of conformity assessment options.
  • Notified Body offer analysis.
  • Notified Body negotiation.

 

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