On October 5, 2015, the Ministers of the EU countries agreed, after almost three years of discussions, on a general approach on the medical devices legislative package. This agreement is a major step towards ratification of new regulations on medical devices and in vitro medical devices that would ensure a higher level of health and safety protection for EU citizens as end users of these devices.
Why are new regulations needed?
The proposal for revision of the existing legislative framework follows multiple device scandals in the EU involving the dissemination of fraudulent breast implants and issues with some metal-on-metal hip replacements that raised new concerns about the safety of medical devices. The new amendments will prevent such events occurring again as it will strengthen the safety of all medical devices available in the EU.
Regulations concerning the safety and performance of medical devices in the EU were harmonized in the 1990s. As such, it is now the right moment for the EU Regulations to be adapted to the significant technological and scientific progress in this sector over the last 20 years. This will guarantee high levels of health and safety protection for all EU citizens using these devices.
The revisions affect home-use items such as: sticking plasters, pregnancy tests and contact lenses, as well as others such as x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
This congruity is based on the technical work of the Permanent Representatives Committee of EU countries which recently concluded, on September 23, 2015, the Council’s position on the draft Medical Devices and IVD Regulations. The fundamental elements of the Council’s position were already agreed in a partial General Approach on the draft EU medical devices package on June 19, 2015. The final agreement of October 2015 is in line with the partial agreement of June 2015. The main difference is that it includes a general approach on the recitals of the draft Regulations on medical devices and IVD.
What is next?
The final agreement on the Council’s General Approach of October 2015 will allow the Council to launch the “trilogue” discussions with the European Parliament and the European Commission. The target is to reach an agreement for the prompt adoption of the new Regulations, expected to be ratified before the end of 2015 or early 2016.
With more than 27 years of experience within the Medical Devices field, the Obelis team is available to closely guide you through the medical device packaging requirements, language provisions and proper translations for full compliance with current and forthcoming EU Regulations.
Please feel free to contact us for more details.