Medical devices are a wide range of products or equipment intended for medical purposes. This category of product covers both: an instrument, apparatus, appliance, software, implant, reagent, material or other article used in humans for:
What needs to be stressed, the principal action of the abovementioned articles shall not be achieved in or on the human body by pharmacological, immunological or metabolic means, however, they may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
The medical devices regulatory framework covers Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR).
The MDR (EC) 2017/745 divides the devices into 4 risk classes based on 22 rules on the classification of medical devices. Medical device classification rules adopt a risk-based approach taking into account the risks associated with the use, technical and manufacturing characteristics of the device.
In the European Union medical devices must undergo a conformity assessment to demonstrate they meet legal requirements to confirm they are safe and perform as intended. The assessment procedure is performed depending on the class of the medical device, which indicates the risk of its use:
SciencePharma can support you to conduct all assessment and notification procedures required by Regulations on Medical Devices (MDR) and In-vitro diagnostic medical devices (IVDR).
We offer consulting services in the field of assessing the potential of various projects development of medicinal products, devices or dietary supplements.
SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies.
Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP auditing services.
We offer multidisciplinary services in the field of Regulatory Affairs including support for pre-registration, registration and post-registration.
Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders have a legal obligation to set up and maintain a Pharmacovigilance system.