Are the procedures for the new Medical Device Regulation 2017/745 still not clear for your company? Fortunately for you, you came across this article. And whether you have never even heard of the new Medical Device Regulation 2017/745 or you are just looking for some extra information, this article will outline all crucial components you need to consider to get your medical device on the European market.
What is it about?
As the title of the Regulation suggests, the Medical Device Regulation lays down rules on medical devices. More specifically it concerns medical devices intended for human use and accessories for such devices that are placed on the European market. No matter what medical device you’re producing, if you want to have it put into use on the European market it must comply with the Regulation.
What qualifies a product as a medical device?
Good question. According to the Regulation a medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for specific medical purposes and does not achieve its principal intended action by pharmaceutical, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The specific medical purposes include but are not limited to aspects like diagnosis, prevention, treatment and replacement.
Not every medical device is the same
Does your product qualify as a medical device? If the answer to that question is yes then the next step is classifying the medical device.
Medical devices are divided into different categories based on their characteristics. A medical device can be classified as a I, IIa, IIb or III risk class. The Regulation contains a comprehensive list of rules that categorizes medical devices into a class. To give you some examples, all non-evasive devices are classified as class I. All surgical invasive devices intended for short-term use are classified as class IIa unless otherwise specified. Devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb. All implantable or long term invasive devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class III.
To do or not to do: manufacturer obligations
Now that you have your medical device figured out, it’s finally time to look into the obligations the Regulation places on your company specifically as a manufacturer. As the manufacturer of a medical device the Regulation imposes several obligations on you. For example, you need to ensure the design and manufacturing of the medical device is in accordance with the Regulation. Other obligations include the establishment and maintenance of a system for risk management as well as drawing up and maintaining the Technical Documentation.
What about the QMS?
As a manufacturer, you will also be required to establish a quality management system (QMS). A QMS indicates that the production line of your medical devise’s is consistent in the quality of products it produces. An applicable standard used for establishing a QMS for medical devises is the harmonized ISO 13485:2016.
The points mentioned above should give you an overview of what the Medical Device Regulation 2017/745 and what it means for you as a manufacturer of medical devices. In case you have any further questions about the Medical Device Regulation please feel free to contact us at CE Solutions and find out what our experts can do for your company.