See EESC opinion in all languages under Related documents at the end of this page.
The EESC reflects in the opinion its view on a package of three Commission proposals: COM(2012) 542 final - 2012/0266 (COD), COM(2012) 541 final – 2012/0267 (COD) and COM(2012) 540 final (INT/665 - 666 and 667).
- The EESC welcomes the recast of the current regulatory system by the Commission that goes beyond a mere simplification of the framework and puts in place more effective rules, strengthening the pre‑market approval procedures and in particular the post-market surveillance.
- The EESC strongly supports the legal form of a "Regulation" instead of a "Directive" so as to reduce the room for diverging interpretation by individual Member States, providing more equality for European patients and a level playing field for suppliers.
- Beside safety, fast access to the latest medical technologies also represents an important benefit for patients. Considerable delays in accessing the new devices would harm patients by reducing their treatment choices (possibly life-supporting) or at least prevent them from reducing their disabilities and improving their quality of life.
- The EESC generally supports high standard approval procedures for high-risk MDs and IVDs before entering the market, in which safety and efficacy must be proven by the results of adequate clinical tests and investigations.
- The EESC welcomes the introduction of a Unique Device Identification (UDI) to be assigned to each device, allowing faster identification and better traceability. The EESC would also welcome a fully workable central registration tool (Eudamed) which would eliminate multiple registrations and considerably decrease the costs for SMEs.
Other relevant EESC opinions on:
- Medical devices / in vitro diagnostic (CESE 1153/1995 - ENVI/407)
- Medical devices incorporating stable derivatives of human blood or human plasma (CESE 1484/2001 - SOC/088)
- Active implantable medical devices (CESE 339/1993 - IND/484)
- Medical devices (CESE 86/1992 - IND/435)
For more information please contact the INT Section Secretariat