Verification of qualification and classification

How do you ensure compliance with the MDR?

Find out what you should do to ensure the compliance of your medical devices with the new MDR Regulation (2017/745).

Person Responsible for Regulatory Compliance PRRC
Verification of qualification and classification
Analysis of harmonised standards
Risk management and analysis
Clinical evaluation
Preparation of the technical documentation
Verification of the technical documentation
Selection and contact a notified body
Product registration
Post market surveillance
Vigilance
Certificate of free sale

Correct qualification and classification of a medical device is crucial for the determination of an appropriate conformity assessment procedure and allows to avoid legal complications and additional costs.

How to qualify and classify a product?

A medical device and an in vitro diagnostic medical device shall be qualified and classified according to its intended use and shall be subject to the analysis of criteria such as time and type of patient contact, degree of invasiveness, mode of administration, presence of potentially hazardous substances.

The correct qualification and classification of a medical device is key to determining the appropriate conformity assessment procedure and avoids the legal complications and additions to the costs associated with placing a medical device with the wrong classification on the market.

How can we help?

Our experts will provide a verification and classification of the medical device, in order to carry out a proper product conformity assessment procedure.