MD and IVD Symbol
The guarantee of safety in medical devices
European Certification
MD and IVD Symbol:
the guarantee of safety in medical devices
Based in Barcelona, with more than 30 years of experience, we specialize in the comprehensive management of medical devices. Our track record allows us to face all the necessary steps for the market launch of your medical devices (class I, Is, Im, IIa, IIb, III) and in vitro (class A, As, B, C, D).
What are they?
Medical Device
Instrument, apparatus, implant, software or material intended to prevent, diagnose, treat or alleviate a disease in the human body, without exerting its main action by pharmacological means.
In vitro diagnostics
Reagents, instruments and systems intended for the examination of samples extracted from the human body —blood, urine, tissues— to obtain information on the physiological or pathological state of the patient.
Risk classification
4 classes according to duration, invasiveness and purpose. The higher the class, the greater the intervention of the notified body.
4 classes based on risk to the patient and clinical impact of the diagnostic result.
Regulatory framework in the EU
Applicable since May 2021. Requires robust clinical evaluation, continuous post-market surveillance and, for high classes, audit by an accredited notified body.
Applicable since May 2022. Introduces a more demanding classification that significantly expands the certification requirements for most manufacturers.
Verification of compliance in labeling
Class I:
CE self-certification + MD symbol
Class Im, Is, IIa, IIb or III:
CExxxx + símbolo MD
Class A:
CE self-certification + IVD symbol
Class As, B, C or D:
CExxxx + símbolo IVD
CExxxx: marking granted by a NB (notified body).