This article was originally posted on our sister blog Inside Medical Devices

On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the medical devices and IVD framework. The European Commission considers this as “a major step forward towards the adoption of new regulations on medical devices to help guarantee a high level of health and safety protection for EU citizens using these products.”

This agreement is based on the technical work of the Permanent Representatives Committee of EU countries which finalized the Council’s position on the draft Medical Devices and IVD Regulations on September 23, 2015. The core substance of the Council’s position was already agreed in a partial General Approach on the draft EU medical devices package on June 19, 2015 (for details please see our previous post of early September). The final agreement of October 2015 does not deviate from the substance of that 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. Preambles of EU legislative instruments do not have a binding effect; however, they are useful in the interpretation of rules and usually consulted by EU and Member State institutions and courts in their application of the law.

For example, as we noted earlier in our September post, the Council’s General Approach does include clarifications on companion diagnostics in the recitals of the draft IVD Regulation, which will be useful in the application of the relevant rules in the future. The compromise text of those recitals is slightly different from the one adopted back in February 2015 and is as follows:

“ (11a) Companion diagnostics are essential to define patients’ eligibility to specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at higher risk of developing adverse reaction to the specific medicinal product or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker(s) may be present in healthy subjects and/or in patients.”

“(11b) It should be clarified that devices monitoring the response to treatment by the corresponding medicinal product for the purpose of adjusting treatment to achieve improved safety or effectiveness of that corresponding medicinal product are considered companion diagnostics. Devices that are used in treatment drug monitoring to ensure that the drug concentration in the human body is within the therapeutic window of the drug are not considered companion diagnostics.”

The final agreement on the Council’s General Approach of October 2015 will enable the Council to initiate the “trilogue” discussions with the European Parliament and the European Commission. The aim is to reach an agreement for the adoption of the new Regulations as soon as possible, in theory even before end of 2015; a more realistic prediction, however, would be to have an agreement sometime in 2016.

Please note that the draft Regulations include transitional periods for application of their rules. The Medical Devices Regulation will apply three years after its entry into force and the IVD Regulation will apply five years after entry into force. Devices which comply with the new rules may be placed on the market even during the transitional periods.

It is important to note, however, that the application of the new framework will have an impact on devices that are already on the market on the basis of the currently in force Directives 90/385/EEC (Active Implantable Devices Directive), 93/42/EEC (Medical Devices Directive) and 98/79/EC (IVD Directive).  E.g., based on the draft Medical Devices Regulation, devices that have been lawfully placed on the market before its date of application may continue to be made available only until five years after that date.  Similarly, the new framework will also affect the validity of certificates issued by notified bodies before and after the entry into force of the Medical Devices Regulation.

The full texts of the General Approach are available online at: