“Medical Devices Regulation – a first regulation for medical devices industries”
MedTranslate Conference 2014, 3-5 October, Freiburg, Germany
Dr. Frank Reininghaus is a chemist (specialized in analytics) and has been working in the medical and pharmaceutical industry for twenty years.
He also participated in courses in business education at the University of Hagen.
He has been working in the software industry for the past 5 years, focusing on medical devices and pharmaceutical companies. During this time, he has also been involved in the approval procedures in the pharmaceutical industry, especially in centralized approval procedures and was the moving spirit for the internal developments regarding PIM at Across Systems.
Since Fall 2012, he’s been focusing on medical devices due to the impact of EU Commission proposals on the regulation of medical devices. He spoke at the tekom main conference about the expected changes in medical devices documentation.
He is also engaged in the field of Change Management and Six Sigma.
Presentation: Medical Devices Regulation – a first regulation for medical devices industries
PIP and its consequences
In April 2010 it was prohibited to sell, market and export any implants from the French company Poly Implants Prothèses (PIP). The reason was that PIP used industry silicon for its mammal implants and due to this a high number of unforeseen occurrences have been notified.
As reaction of the European Commission a “Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009“ has been published as well as an equivalent regulation on in-vitro diagnostics in September 2012. The idea of the European Commission was to implement a similar institution as the EMA, which is responsible for central approvals of drugs in Europe or the FDA (food and drug administration) in US to prevent any further accidents as PIP and to have a more concrete and direct overview on unforeseen accidents on a central European level.
During the last year these proposals have been discussed between the stakeholders and the different European Union parties.
On 2 April 2014 the European Parliament formalized their first reading position which is the same as the amendments to the European Commission proposals, which were approved by the European Parliament in October 2013. The Parliament voted in favour of a number of changes to the proposed regulations.
We hope to get a final vote for the regulations end of 2014 or beginning of 2015. This will be followed by a three year transition period leading to a start of the new regulation latest in 2018.
The impact of the regulation on the documentation of medical devices will be shown in this presentation.