CMI Medical | CENTER FOR CERTIFICATION OF MEDICAL DEVICES

Our vision

Our aim is to combine a high level of expertise with impartial, transparent and clearly conducted conformity assessment. We strive for a clearly defined and as predictable a process as possible, while rigorously maintaining the notified body's independence and objectivity. Responsibility for the medical device's conformity with the MDR remains with the manufacturer; CMI's role is to independently assess whether the applicable requirements are fulfilled.

Scope of notification

The scope of notification determines the devices and procedures for which CMI, as a notified body, may carry out conformity assessment. One of the first steps for a manufacturer is therefore to verify whether the intended assessment falls within CMI's current scope. What matters is not a single item of information, but a combination of the device characteristics, relevant MDR codes, risk class, selected conformity assessment procedure and any limitations or special procedures.

For practical orientation, it is useful to consider three interrelated areas:

1. MDR codes

MDR codes are used to define the notified body's scope of designation and the expertise required to assess a particular device. The individual groups of codes serve different purposes:

• MDA / MDN: basic codes reflecting in particular the design and intended purpose of the device.
• MDS: horizontal codes reflecting specific characteristics of the device, such as sterile condition, the use of software or nanomaterials.
• MDT: horizontal codes describing manufacturing technologies and processes that are particularly relevant to the planning and conduct of audits.

When reviewing the information provided, CMI verifies whether the relevant combination of codes falls within its scope and whether it has the appropriate expert resources available for the requested assessment. An overview of CMI's current codes is available on the CMI scope for conformity assessment.

2. Risk class and conformity assessment procedure

The risk class of the device affects whether the involvement of a notified body is required and which conformity assessment procedures are applicable under the MDR. For class I devices, the notified body is involved only for devices placed on the market in sterile condition (Is), devices with a measuring function (Im) and reusable surgical instruments (Ir), and only with regard to the relevant aspects.

• Conformity assessment procedure: the procedure selected under Article 52 and Annexes IX to XI of the MDR must be included in the scope for which CMI is designated.
• Conditions and limitations: the scope may contain specific conditions or limitations. A match with a single MDR code alone therefore does not necessarily mean that every device falling under that code can be assessed by the notified body concerned.

If you are only beginning to prepare for assessment, the basic relationships between classification, documentation and the choice of procedure are summarised on the Preparing for the conformity assessment process at CMI.

3. Special procedures and additional requirements

For some devices, the MDR provides for additional specific procedures or consultations, for example for devices containing a medicinal substance, certain tissues or cells, or devices subject to the clinical evaluation consultation procedure (CECP).

• Applicability of the procedure: depends on the specific characteristics of the device and the selected conformity assessment procedure.
• CMI scope: CMI may carry out the requested assessment only if it falls within its valid scope of designation and the necessary expert and procedural resources are available.

The official scope of CMI's notification is available in the European Commission's Single Market Compliance Space (NANDO) database. An overview of CMI's current scope, including information on the planned extension, is also available on our CMI scope for conformity assessment.