NEW devices covered by the IVD Regulation
The new EU IVD Regulation 2017/746 has been approved on 5th of April 2017 and it came into force on May the 26th2017. One of the crucial changes brought about by the new Regulation is the enlarged field of devices’ types covered by the new dictum.
The aforementioned changes surely pleased all the manufacturers dealing with innovative In-Vitro Diagnostic Devices. In fact, many manufacturers of such devices had previously faced considerable amount of problems while trying to bring their devices to the EU market under the previous directive. It was hard to comply with the legislation that was not directly (or even not at all) covering or classifying them. Manufacturers were often literally hoping for a broader interpretation of the law by the Competent Authorities while notifying their products. The new Regulation is finally managing to fill in this gap between the Law and the Innovation.
What is actually allowing new devices to be included in the new IVDR is the new definition of In-Vitro Diagnostic Device itself, which has been greatly expanded. The new IVD definition will now include products such as: genetic tests, tests that are used to predict treatment response or reactions, and medical software.
Another broadening of the IVDR scope is outlined in the Article 5 of the Regulation on the ‘’Distance sales’’. The article is including under the compliancy of the Regulation the devices offered by means of information society services as well as the devices that are not placed on the market but used in the context of a commercial activity for the provision of a diagnostic or therapeutic service offered by means of information society services. It means that the IVDR will cover Healthcare services offered on a long distance, such as Diagnoses and Data analysis delivered using web systems or interactive exchanges between clinical facilities and laboratories abroad.
Let’s enter the EU Market
Should you be one of the manufacturers interested in affixing a CE mark on the IVD device, or should you still be unsure about classification of your devices and the related compliance route, Obelis Experts will be delighted to assist you with their EU Regulations expertise. Please do not hesitate to contact us!