On 19 June 2015, the Employment, Social Policy, Health and Consumer Affairs Council adopted a partial general approach –excluding the recitals- on the Medical Devices and In Vitro Diagnostic Medical Devices Regulations.
After three years of debate, this achievement represents an important milestone in the adoption of new legislation on medical devices. It needs to be remembered that the European Parliament adopted its position in October 2013 but negotiations could not continue between the institutions until the Council agreed on a general approach.
Under the mantra ”Let’s not make the best the enemy of the good”, most delegations (with the exceptions of Germany and Poland) agreed to move to the next stage, despite not fully agreeing with the outcomes on some elements of the general approach.
The most controversial topics are still the premarket assessment of high risk devices, reprocessing, inclusion in the scope of the legislation of aesthetic products and the unique device identification system, which will constitute the main subjects of discussion in the trialogues ahead.
As a next step, the Council needs to finalise the outstanding technical work concerning the preamble of the two draft regulations (which give important clues for interpretation of the articles in the body of the regulations) and check technical inconsistencies with a view to preparing a general approach for the two draft regulations. Trialogues are due to start in autumn.