The European Commission has released its proposal for future regulation of medical devices, which replaces three current directives on active implantable medical devices (AIMD), medical devices (MDD), and in vitro diagnostic medical devices (IVDD) with one regulation covering all medical devices and one regulation for IVDD.
These proposed rules are designed to bring legislation in line with the pace of technological and scientific progress over the last 20 years and bring uniformity to interpretation and implementation in various EU member states.
Main changes proposed for AIMD/MDD include:
- Wider and clearer scope of EU legislation to include implants for aesthetic purposes, and human tissue-derived devices
- Stronger supervision of notified bodies by national authorities
- More powers for notified bodies vis-à-vis the manufacturers to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites
- Clearer rights and responsibilities for manufacturers, authorized representatives, importers, and distributors, including in the case of diagnostic services and Internet sales.
Main changes proposed for IVDD include:
- Employing classification and conformity routes based on the Global Harmonization Task Force but adapted for the EU regulations
- Under further requirements for in-house assays, Class D devices will be fully under the scope of the IVD Regulation, Classes in A, B, and C used within a single healthcare institution are exempt from the regulation provided they are made and used in an accredited laboratory
- Specific definition and requirements for Companion Diagnostics are defined as a device intended to select patients with a previously diagnosed condition or predisposition for eligibility of treatment with a specific medicinal product and will become class C devices
- New labeling requirements such as complying with unique device identification requirements