The Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
This episode of Business Planet looks at what makes the French city of Lyon an entrepreneurial stronghold. The team visit a successful business in the medical industry that uses a unique tool to treat the eye disease glaucoma.
Policy preparation at the European Commission is supported by both retrospective evaluations and forward-looking impact assessments.
This episode of Business Planet comes from the German city of Bonn. The team looks at a unique partnership between researchers, universities, pharmaceutical giants and small and medium-sized enterprises (SMEs) aimed at providing new treatments for patients and business opportunities for entrepreneurs.
The European Parliament and the Council have reached an agreement for better surveillance and traceability of medical and in vitro diagnostic devices.
The new lists of references of harmonised standards for medical devices have been published (OJ C 173 of 13 May 2016). They can be found below.
This study presents key quantitative analysis on the exponential growth of trade in counterfeits and pirated goods worldwide. It highlights emerging trends, both globally and at country level, and the key industries affected by this illegal activity.
On 19 May, the Regulatory Committee on Medical Devices voted in favour of the Commission decision on the qualification of cranberry products.
In this episode of Business Planet, Anne Glémarec goes to Barcelona, Spain to see how some small and medium-sized enterprises (SMEs) are becoming more competitive by better protecting their innovations.
Ministers of all EU countries have agreed on the general approach to the medical devices package. This is a significant move on the way to the adoption of new regulations on medical devices, to help guarantee a high level of health and safety protection for EU citizens using these products.
New lists of references of harmonised standards for medical devices have been published (OJ C 226 of 10 July 2015). They can be found below.
Following the publication of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company, the European Commission requested to conduct further in-depth study on the potential health impact of faulty breast implants.
Ranging from simple sticking plasters to the most sophisticated life-supporting machines, medical devices and in vitro diagnostic medical devices are central to our health and quality of life.
On 30 August 2012 new consolidated lists of references of harmonised standards under the three (main) medical devices directives were published in the Official Journal of the European Union.
The European Commission has launched a public consultation on the technical aspects of the revision of Directive 98/79/EC on in vitro diagnostic (IVD) medical devices
