Contents of Article 61 of the MDR

Article 61 of the Medical Device Regulation (MDR) deals with the clinical evaluation of medical devices.

Here are the main points summarised in an overview of Article 61 of the MDR regarding the clinical evaluation of medical devices:

1. Conformity with safety and performance requirements must be based on clinical data that provide sufficient clinical evidence.
2. Manufacturers must define and justify the required level of clinical evidence.
3. Manufacturers must plan, conduct and document a clinical evaluation.
4. For class III devices and certain class IIb devices, manufacturers may consult an expert panel prior to clinical evaluation.
5. The clinical evaluation follows a defined procedure that includes the following:
   a) Critical evaluation of the relevant scientific literature
   b) Critical evaluation of the results of all available clinical investigations
   c) Consideration of available alternative treatment options
6. Clinical investigations must be conducted for implantable devices and class III devices, with some exceptions.
7. The clinical evaluation and its documentation must be updated throughout the life cycle of the device.
8. Special requirements apply to devices without an intended medical purpose.
9. In cases where a clinical evaluation does not appear appropriate, sufficient justification must be provided.

Manufacturers should address clinical evaluation at an early stage and dovetail it with other mandatory processes. Well-trained specialists are essential for this.

Can we support you too? Please contact us at here!