In September a renewed draft the new Medical Devices Regulation was presented, which will replace the existing Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC on active implantable medical devices. After a large number of changes from the previous draft were incorporated, it can be assumed that the draft regulation now is already close to the final status. Some significant changes relate to:
► Traceability by implementing a Unique Device Identifier (UDI),
► unannounced audits at the supplier’s sites and their quality-critical suppliers by the notified bodies,
► introduction of a Medical Device Coordination Group within the EU-commission, that will assess high-risk products,
► Post-Market Surveillance and Post Market Clinical follow-up as processes to be implemented in the organization.
One thing is certain: The regulatory requirements for medical devices continue to grow!
At this point we would like to pick out the clinical evaluation as an example. This will in future no longer be limited to an analysis of clinical data from the literature and studies only; it must in addition also be included as a process deeply into the quality management system of the manufacturer. Information can be found in Annex XIII of the draft regulation. The following amendments are to be expected:
► It establishes a Clinical Evaluation plan in which the intended clinical benefit of a medical device will be described with reference to specific data. The methods to study the clinical safety must be specified and refer to the risk analysis. Risk / benefit assessments must be attributed to individual components of the product.
► A Clinical Development Plan is to describe the development under clinical aspects from the first studies and pilot studies to Post Market Clinical follow-up, and define appropriate milestones and acceptance criteria.
In the meantime, a draft of a new MEDDEV document for clinical evaluation has also been released, which partially describes analog aggravations.
For implants and class III products clinical trials are likely to be mandatory by the draft regulation, unless the notified body has recognized the product as a modification of a product already available on the market for which corresponding study data is available. Products from other manufacturers may be used as an equivalent in this case only if access to the technical documentation for the equivalent product is given. For competitive products this will often be impossible (see. Article 49, paragraph 2).
As your regulatory partner, we recommend to move swiftly forward with your development projects in order to use the time up to the introduction of the new regulation and the transition periods, or align new projects accordingly already. It is assumed that the regulation will come into force in 2016 with a transitional period of three years. We will be happy to support you in the new year with all regulatory matters and in adapting your quality management system. We will also keep you up to date on the development of new regulation.