Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
News

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of Septemb [...]

MEDDEV 2.7/1 – new guidelines on clinical evaluations
News

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and [...]

EU to release NEW Medical Device Regulations!
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In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Par [...]

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions
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The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (more…) [...]

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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