Ranging from simple sticking plasters and contact lenses to sophisticated implants and dental materials, medical devices are very important to health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation.
HTCert provides services for Medical Devices which are currently regulated within the EU by Council Directive 93/42/EEC on Medical Devices (MDD) (1993).
On 5 April 2017, a new Regulation (EU) 2017/745 was adopted, and it is entered into force on 25 May 2017, replacing the existing Directive.
The new rules will only apply after a transitional period of 3 years after the entry of the Regulation into force.