By 26th May 2022, all IVD equipment/devices will transition to the new medical device regulations EU 2017/746. This regulation will be mostly for devices that are for self-testing, near-patient testing, and rapid tests to add specific symbols/labels on their products.
For self-testing – This symbol indicates that the medical device is a self-test in vitro diagnostic device. With this device, anyone can easily use it without requiring a doctor’s support. Examples of this self-testing equipment are ovulation tests, pregnancy tests, and other tests that can be purchased from a pharmacy or a drug store.
Not self-testing – The not-for self-testing symbol illustrates that a device is not for self-testing (the device will require a trained medical professional). It is advisable to add this symbol close to the "for the near-patient testing symbol." Some examples of search devices are tests used to detect streptococcal antigens in the throat and tests used to determine allergies from a blood sample.
For near-patient testing – The near-patient testing symbol illustrates that a device can only be used in a near-patient setting by a health worker, professional, or trainee. These devices should not be used by patients themselves. Individuals who have acquired knowledge on how to use the specific device will be assigned to use the device on the patient. The most common example of near-patient devices are found in first aid kits, ambulances, emergency units, clinics, hospitals, and workplaces should have this symbol. Some of the devices that require this symbol are urine tests and rapid screening for drugs.
Not for near-patient testing – This symbol is to be placed on devices that are to be used by only a trained medical professional or laboratory professional. These devices will be put on rapid tests that are intended for only laboratory environments. This might include handheld drug rapid tests, blood coagulation tests, and several others.
All medical devices that are subjected to the new IVDR would require to put these labels on their products. All labels should be placed on the product and should be clearly legible and indelible. If all the labels cannot be put on the product, the IVD manufacturer will be required to place the labels/symbols on the packaging for each IVD product.
How can EuroDev help?
The European Business Development Group maintains partnerships with North American companies. Through the offering of a variety of business expansion services, EuroDev has played a pivotal role in the European expansion of over 400 North American companies since 1996. For further market, information, contact us at e-nijland@eurodev.com. Your partnership with EuroDev can accelerate submissions and approvals for manufacturers who want to expand into these markets.
About EuroDev
EuroDev, established in 1996 with offices in The Netherlands and France, has a single, defined purpose to help mid-sized North American companies expand their business in Europe. We have created a proven, successful business development model and since our founding, have partnered with over 400 companies to help them define and meet their European business goals. Services provided include Sales Outsourcing, HR Outsourcing and Digital Marketing.
