Medical devices
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:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury/handicap;
- investigation, replacement, modification of the anatomy or a physiological or pathological process or state;
- providing information using in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.
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:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilization of 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.
- Class I (most non-invasive devices) e.g.:
- Stethoscopes
- Eye occlusion plasters
- Wheelchairs pushed by hand
- Corrective spectacle frames (i.e. glasses) and lenses in frames
- Class IIa e.g.:
- Syringes with needles, syringes for infusion pumps
- Devices intended to channel blood
- Fridges and freezers specifically intended for storing blood and tissues
- Fixed dental prostheses
- Tracheal tubes
- Surgical gloves
- Clamps
- Class IIb e.g.:
- Ventilators
- Infusion pumps
- Anesthesia machines
- Fertility monitors
- Active coal for oral administration
- Class III g.:
- Breast implants
- Surgical meshes
- Total or partial joint replacements
- Spinal disc replacement
- Prosthetic heart valve
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:
- For risk class I medical devices (non-sterile, without a measuring function and not a reusable surgical instrument) the manufacturer independently conducts the conformity assessment, issues a declaration of conformity and marks its product with the CE mark (self-certification, Conformité Européenne mark).
- For devices with higher risk classes (II – III) and classes Is, Im and Ir, a notified body must participate in the conformity assessment procedure. The higher the class of the device, the greater the involvement of a notified body in conformity assessment.
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).
Research and development
We offer consulting services in the field of assessing the potential of various projects development of medicinal products, devices or dietary supplements.
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Audits
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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.