Class I

Class IIa

Class IIb

Class III

Medical devices with little risk to human body if they fail

Medical devices with relatively little risk to human body if they fail

Medical devices with  with relatively high risk to human body if they fail

Medical devices that are highly invasive and may directly endanger the patient's life if they fail

Classification of Medical Devices

Medical Device Trials

We are the CRO supporting medical device's developing companies in execution of medical device evaluation.

We work under The Act of 20 May 2010 on medical devices. We will help you to comply with the section concerning classification, evaluation of medical devices, certification and execute the rules for submitting notifications for products and manufacturers, authorized representatives, importers and distributors of medical devices. Clinical Consulting act also as EU Legal Representative.

Medical Devices are divided into classes. Classification of a medical device is very important. It determines the type of conformity assessment procedure to be carried out by the manufacturer to ensure that the choice under assessment meets the essential requirements. The higher the product class, the more restrictive the conformity assessment procedure.

The result of the clinical evaluation is whether the device is safe for humans.

Medical Device Evaluation

With regard to intended use, medical devices are assessed on the basis of available clinical data from similar devices – e.g. scientific articles. If there is no sufficient data, non-therapeutic study to obtain such information can be performed. Devices classified to class III need to be evaluated in clinical trials.

We help to place devices on the market by obtaining sufficient data to CE marking (after conformity assessment procedures).

Safety Evaluation

Efficacy Evaluation

Non-therapeutic studies

Questions?

Regarding medical device and its evaluation do not hesitate to ask us!

Definition

Clinical data

information on the safety or performance of the medical device, medical device equipment or active implantable medical device, obtained as a result of their use, derived from:

(a) published or unpublished reports from other studies with the use of the medical device, for which equivalence to the medical device can be demonstrated.

(b) a clinical trial or other studies the results of which have been published in the scientific literature, and concern a similar medical device, for which equivalence with the medical device can be demonstrated.

(c) clinical trial of the medical device concerned.

Laws we obey

  • 93/42/EEC
    The Council of the European Union Directive of June 14, 1993 Concerning medical devices.

  • 90/385/EEC
    The Council of the European Union Directive of June, 20 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.

  • 98/79/EC
    The European Parliament and The Council of the European Union Directive of October, 27 1998 on in-vitro diagnostic medical devices.

MEDDEV guidelines are:

  • MEDDEV 2.4/1
    Guidelines relating to the application of The Council Directive 93/42/EEC on medical devices. Classification of medical devices

  • MEDDEV 2.7/1
    Clinical evaluation: Guide for manufacturers and notified bodies under Directives 93/42/EEC and 90/385/EEC.

  • MEDDEV 2.7/3
    Clinical investigations: serious adverse event reporting under Directives 90/385/EEC and 93/42/EEC

  • MEDDEV 2.12/1
    Medical devices vigilance system.

 

ISO quality management system:

  • ISO 14155
    Clinical investigation of medical devices for human subjects - Good Clinical Practice.

  • ISO 14971
    Medical devices - application of risk management to medical devices.

  • ISO 15223-1:2017-02
    Medical devices - symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements