On September 26, 2012, the EU Commission released its proposal for future regulation of medical devices. Within the package, the current three Directives on active implantable medical devices(AIMD), medical devices (MDD)as well as in vitro diagnostic medical devices(IVDD) are replaced by two Regulations, one covering all medical devices, the other covering IVDs.
These new rules are proposed for a number of reasons, including the need to bring legislation in line with the pace of technological and scientific progress over the last twenty years. In addition, the proposed changes bring uniformity as current Directives lead to different interpretations and implementations in the various EU member states and consequently to different levels of patient and public health protection in the EU. The new Regulations also aim to improve traceability and transparency.
The revision was initiated in 2008 well before recent events such as the scandal about fraudulent silicone breast implants and the problems occurring with certain metal-on-metal hip joint replacements which have brought the topic of Medical Device Regulation to the attention of the public at large. Lessons learned have been used to strengthen the system and ensure it is ready to face the future.
The proposal includes more details on medical devices and on IVDs but also improves the possibilities of short-term further provisioning by referring to amending and implementing acts that can be added in the future. The proposal will now be reviewed as it passes to the EU parliament and the Council of EU ministers, who will start analyzing and discussing the proposals. These co-legislators need to jointly conclude on the final text of the future Regulations. If after the first reading the documents are adopted, finalization should take circa 18 months. If significant change or debate occurs the lead time will increase. On final agreement the texts will be published in the Online Journal of the EU, the legislation will then gradually come into force with a final transition timeline of three years (MDD) and five years (IVD) post-publication (OJEU).
Read more about the rationale and objectives of legislative reform.
Main changes proposed for AIMD and MDD
- The MDD with become a Regulation rather than a Directive
- Wider and clearer scope of EU legislation, extended 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
- Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market
- Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls)
- Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices
- Adaptation of the general health and safety requirements, including labeling provisions, to the technological and scientific progress
- A limited number of reclassification (orthopedic implant, aphaeresis equipment)
- Creation of a Medical Device Coordination Group (MDCG) composed of members representing national competent authorities in the field of medical devices to ensure better coordination between the Member States, with the Commission providing the necessary scientific, technical and logistic support
- The Notified Body will have to inform the MDCG of all new high-risk applications and submit a summary of safety and performance, the MDCG can request additional information within 15 days and additional information within 90 days, this does not apply to changes to existing products
- Each manufacturer and authorized representative will require a Qualified Person with 5 years regulatory experience to be responsible for the conformity of batches to be released, maintenance for the technical documentation and declaration of conformity plus vigilance reporting
Read the full proposed changes to the AIMD and MDD.
Main changes proposed for IVDD
- The IVDD with become a Regulation rather than a Directive
- It will employ classification and conformity routes based on the GHTF but adapted for the EU regulations
- The Regulation will apply from the point a product is made available rather than the point it is placed on the market
- 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 they 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
- The specific definition and requirements for devices for near-patient testing include devices intended to perform testing outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, the patient and will be regulated in a similar way to self-test devices
- New labeling requirements including UDI requirements
- There are increased requirements for post-market surveillance (PMS) including a PMS plan a post-market clinical follow-up plan and a post-market clinical follow-up evaluation report for each device
- The Notified Body will have to inform the MDCG of all-new Class D applications and submit a summary of safety and performance, the MDCG can request additional information within 15 days and additional information within 90 days, this does not apply to changes to existing products
- The regulation will establish the requirements for a network of reference labs which will support the establishment of the state of the art, creation of CTSs and pre-certification independent testing to the CTS, support the verification of manufactured product for Class D and other testing requirements needed by the Competent Authority or Notified Body
- Increased clinical evidence will be required, there are more definitions associated with clinical requirements including requirements for studies including the requirement for a sponsor and also requirements for interventional studies and their registration
- Each manufacturer and authorized representative will require a Qualified Person with 5 years IVD regulatory experience to be responsible for the conformity of batches to be released, maintenance for the technical documentation and declaration of conformity plus vigilance reporting
Read the full proposed changes for the IVDD.
