Tag Archives: mdr guidelines for medical devices

Definition:  Borderline products are ones for which it is unclear whether they come under MDR or MDP from the start. If the product is subject to MDR, it must comply with MD Article 2(1) and must not be within the scope of MDR Article 1(6).  thanks to new tips provided by way of the european commission’s medicalContinue reading “latest Guidance on Borderline Products as per MDR”