A medical device is defined as “any instrument, appliance, equipment, material, product, or other article used alone or in combination for medical purposes; whose main intended action is not achieved by pharmacological, immunological or metabolic means but whose function may be assisted by such means. What also constitutes a medical device is the software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes.
This definition corresponds to thousands of products that vary in weight, size and cost of production, all with the same objectives: to prevent, diagnose, control and mitigate injuries, illness or disability.
Examples include a syringe, scanner, implantable prosthesis and operating room equipment.
The New Legislative Framework
The new legislative framework (or NCL) is a unique legal framework allowing the placing on the market in Europe of many consumer products. It defines a level of requirement to be achieved to ensure the safety of consumers without prejudging the technical solutions to be implemented to achieve this. The new approach applies to many products, in which more than 24 sector directives have been developed. Products which comply with this framework bear the CE marking which is the visible symbol of the conformity of the products with all the applicable legislation in the field of safety.
The CE Marking
The CE marking guarantees the free movement of safe products within the European Union. The European directives (Directive 93/42 EC for medical devices and Directive 90/385 for active implantable medical equipment) lay down essential requirements which are intended to ensure the safety and health of persons. To achieve these results, those responsible for the placing on the market of products (manufacturers) must follow specifications which are defined in standards known as “harmonised standards”. The list of applicable standards for the relevant Directives is published in the Official Journal of the European Union. Compliance with these standards for the placing on the market of products gives manufacturers a “presumption of conformity”.
The main principles of the CE marking are:
- Manufacturers’ liability
- Third Party Certification
- Clearance checks by the competent authorities
The New Regulation for Medical Devices
After several years of discussions, Regulation No. 2017/745 of 5 April 2017 on medical devices repealing Directives 93/42 EC and 90/385 / EEC was published in the OJEU on 5 May 2017.
This regulation has a significant impact on the sector and all its players. The new provisions amend the rules on the placing on the market and putting into circulation of devices, the obligations of the various economic operators, the CE marking, traceability, IDU, notified bodies, classification of devices, conformity assessment, clinical evaluation and investigations, vigilance, etc. Also, the Regulation covers certain non-medical products such as non-corrective contact lenses, liposuction equipment, pulsed light hair removal.
The date of entry into force of the new Regulation is 26 May 2017 and most of its provisions will enter into force three years later, i.e. 26 May 2020. The new requirements will be directly applicable in all Member States without transposition into national law, thus enabling harmonisation of regulation within the EU.
The Regulation is available in all the languages of the Union via the following link.
Forest Medical Devices Calibration
Ensure that your devices meet CE Standards and are correctly calibrated to display true readings by contacting Forest Medical today. Our services include, either carrying out calibration at your premises or if more convenient to yourself we can arrange a collection and delivery service to undertake Spirometer Testing in our fully equipped workshop. Our engineers can calibrate all makes of Spirometer units including Vitalograph, Micro Medical, CareFusion, Spirolab and any other manufacturers.
Forest Medical aims to reward their clients for repeat medical calibration and testing services on a yearly basis. There are various benefits to this agreement, which include:
- Your medical diagnostic equipment is checked and maintained on an annual basis.
- A fixed price for the duration of the contract. This means that you will know in advance your annual calibration costs.
- Free technical support.
- The confidence that your medical equipment is cared for by a company that holds the ISO 9001:2008 award.
- Forest Medical will contact you prior to your renewal date.