The European Parliament and the Council have reached an agreement in June 2016 for better surveillance and traceability of medical and in vitro diagnostic devices after the negotiation of comments and concerns from the European Commission.
This set-up for improvements started after some international scandals of devices placed on the market. Brussels recognized that the Directive from 1993 [93/42/EEC] was old-fashioned and needed a “renovation”.
This new agreement contains a series of important improvements to the current system.
One of the changes is that the Medical Device DIRECTIVE will be replaced by a Medical Device REGULATION, which means that it is no longer up to the countries how to translate the requirements in their laws, but the requirements should be taken over in its entirety across the EU. This has large consequences for the Competent Authorities, Notified Bodies and Economic Operators.
The Council has planned to approve the agreement at ministers' level this month. Following their legal-linguistic review, the draft will then be adopted by the Parliament and the Council, probably at the end of the year or early 2017. The new rules will apply 3 years after publication for medical devices and 5 years after publication for in vitro diagnostic medical devices [REF 1]
The proposed Regulation “lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices and accessories to medical devices for human use in the Union. This regulation also applies to clinical investigations on medical devices conducted in the Union. Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.” [REF 2]
Key elements of the existing regulatory approach, such as the supervision of Notified Bodies, conformity assessment procedures, clinical investigations and clinical evaluations, vigilance and market surveillance will be significantly reinforced, whilst provisions ensuring transparency and traceability regarding devices will be introduced, with the aim to improve health and safety.
Did YOU know that with implementation of the Medical Device Regulation (MDR):
- Common Specifications (CS) are THE instruments for the MDR?
o Common Specifications can be adopted by implementing acts where no harmonized standards exist or where relevant harmonized standards are not sufficient by the National Authorities!
o The new mechanism of CS will be used to provide design requirements, general safety and performance requirements, the technical documentation, the clinical evaluation and post-market clinical follow-up (PMCF) and the requirements regarding clinical investigations.
- Health institutions are expected to start communicating their device status to the patients?
o Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices (e.g. sterile operating equipment) within the health institution and, where appropriate, any other relevant information on the reprocessed device the patient is treated with.
- The MDR is referring to Economic Operators?
o Economic Operators are Manufacturers, Authorised Representatives, Importers, Distributors, System or procedure packs “builders”, Sterilizers of? packs.
o This will mean increased control by the manufacturer of the total supply chain
- The MDR will introduce UDI (Unique Device Identification), which will replace GMDN?
o The (‘UDI’) system is a system that is already applied in the United States and shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices
- The UDI shall be used for reporting serious incidents and field safety corrective actions and the Basic UDI device identifier of the device shall appear on the EU declaration of conformity
- The MDR will reinforce the requirement for manufacturers to collect data about the real-life use of their devices?
- With implementation of the MDR Software will be clearly classified as a Medical Device?
o It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is qualified as a medical device.
o Software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being application is not considered a medical device.
Rescop prepared a preliminary analysis of consequences/impact of the DRAFT Medical Device Regulation, based on available online publications. Rescop’s Preliminary checklist/presentation is available on request.
Senior GxP Compliance Consultant