On 26 September 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council on medical devices and in vitro diagnostic (IVD) medical devices. These regulations, once adopted, will replace the existing three medical devices directives (MDD, AIMD, IVD).
The MDD and AIMD will be incorporated into one single regulation, the MDR. For current IVD directive, the new regulation will be the IVDR.
The new Medical Device Regulation affected all kinds of medical devices, from home-use items like sticking plasters and contact lenses, to X-ray machines, pacemakers, breast implants and hip replacements. The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices.
Ensuring compliance to the new regulations is critically important for legal manufacturers in order to CE mark their devices in Europe. Manufacturers however will also benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation. The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.
The webinar provides an introduction to the Medical Device Regulation for anyone involved with the medical devices industry.
EXPERT PROFILE: Alberto Paduanelli
Alberto is an experienced medical device lead auditor, having audited a range of medical device companies of all risk classifications, to ensure that they meet their regulatory requirements. He has worked for two Notified Bodies and is currently a Lead Auditor for the Medical Health Services department of TÜV SÜD Product Service in the UK. Prior to re-joining TÜV SÜD Product Service, Alberto worked as Certification Manager for a UK Notified Body.
Alberto has a degree in electronic engineering and his primary expertise is in active medical devices, he also provides training for MDD, Risk Management, ISO 9001, ISO 13485 and Functional Safety, among various webinars presented and offered through our TÜV SÜD website.