To launch a medical device on the EU market, it is necessary to acquire EC type-examination, EC declaration of conformity, CE marking, and Clinical Evaluation. Legislation for healthcare devices in the EU is not simple. However, when the one studies all the documentation provided, it becomes much more clear.
All the solutions developed should comply with safety principles eliminating or reducing risks with adequate protection measures.
The first step in the healthcare devices legislation procedure is EC type-examination when a notified body ascertains and certifies a device sample fulfills the Directive provisions. EC declaration of conformity is a part of the examination procedure whereby manufacturer fulfills all the aspects stated in the EC type-examination. In addition, a manufacturer has to affix CE marking (a claim defining that a product meets the requirements of all European Medical Device Directives).
Clinical evaluation is the last step, confirmation of conformity evaluating the characteristics and performance of a device. It is a demonstration of a device and data demonstrating compliance with essential requirements. Devices from Class III must be clinically investigated.
A manufacturer has to check all the European standards and the product’s compliance with them when getting the declaration of conformity and CE marking. After that, a manufacturer is expected to prepare a technical dossier including proofs of the compliance. They should be checked by an independent body. The CE marking should be visible, legible, and indelible on the product. Moreover, it should include the identification number of an independent checking body. As a final step, a producer should draft and sign an EU declaration of conformity mentioning that the product complies with all the regulations.
To draw up a declaration of conformity, a manufacturer must lodge an application for assessment of its quality with a notified body. It should include the name and address of the manufacturer, the relevant information about the product, declaration stating that there are no other applications lodged for the same product, the documentation on the quality system.
Additionally, a manufacturer should include documentation with intended use of a healthcare device, design specifications, data about the materials used, if it incorporates an integral part, a substance or a human blood derivative and the data of the tests conducted, pre-clinical evaluation, clinical evaluation, the tests and trials which will be carried out before, during and after manufacture. The manufacturer must authorize the notified assessment and team to carry out all the necessary inspections.
For Class IIa devices, assessment commission should check the technical documentation at least one sample from each device subcategory. For Class IIb devices — at least one sample from each generic device group.
To get the CE mark, a device needs to pass the assessment process of compliance. To make it more time and cost efficient, they developed a classification system, so that to assess different types of medical devices properly. So, it is preferable to know from the very beginning which жclass your product belong to. The classification is based upon the levels of potential hazards a device can extend on a human body.
The documentation defines several types of medical devices. Invasive devices penetrate inside the body and non-invasive devices. Active medical devices are the ones that depend on a source of electrical energy or any other type of power source not generated by a human body directly or gravity. Devices with measuring function intended to measure quantitatively physiological or anatomical parameters.
All non-invasive devices belong to Class I.
Non-invasive devices that channel or store blood, body liquids or tissues, liquids or gasses for further infusion, administration, or introduction to the body belong to Class IIa is they connect to the Class IIa devices or higher, and if they are used to store and channel blood, other body liquids, or organs. In all the other cases, such devices are in Class I.
Non-invasive devices that modify biological or chemical composition of blood or liquids that are to be infused into the body belong to Class IIb. If the process consists of filtration, centrifugation or exchange of gas or heat, it is Class IIa.
Non-invasive devices that contact with injured skin belong to Class I if they are used as a mechanical barrier to compress or absorb exudates. If such devices are used directly with wounds with breached dermis, they belong to Class IIb. In all other cases, the devices belong to Class IIa.
Invasive devices intended for body orifices, if not surgically invasive or not intended for connection to active medical devices, belong to Class I. If they are for short term use, they belong to Class IIa, if for long term use — Class IIb. If they are intended to connect with active devices, they belong to Class IIa.
Surgically invasive devices for a short term use belong to Class IIa. If they are developed to be directly implemented to heart, central circulatory system, or central nervous system then it is Class III.
Long-term implantable devices belong to Class IIb, unless they are to be placed in teeth (Class IIa), will have a direct contact with the heart, central circulatory system or central nervous system (Class III).
Active therapeutic devices that administer or exchange energy belong to Class IIa if they do not administer or exchange energy to and from a human body in a hazardous way (Class IIb).
Active devices for diagnostic purposes belong to Class IIa unless they monitor vital physiological parameters (Class IIb). Devices that emit ionizing radiation for diagnostic and therapeutic interventional radiology (Class IIb).
Active devices that administer and remove medication, body liquids and other substances to or from the body belong to Class IIa.
Devices that incorporate as an integral part in a human blood derivative belong to Class III.
Devices that record X-ray diagnostic images belong to Class IIa.
Healthcare software developed for the devices belongs to the same Class.
Clinical evaluation should be conducted for the medical devices of any class.
Instructions for use are not obligatory for the Class I and IIa if a device can be safely used without instructions.
To sum up, legislation procedure for the medical devices is not so simple in the EU. However, if you thoroughly read all the documentation provided on the EU sites, it becomes more clear.