2017 – Expected ‘Year of the IVD and MD Regulations’

Posted on 10.02.2017


The Commission is currently carrying out the first evaluation of the EU blood and tissues and cells legislations (published in 2002 and 2004) to assess if they have achieved their original objectives and whether they are still fit for purpose.

The evaluation will consist of several steps starting with a Roadmap and including a study and extensive consultation of stakeholders. The final evaluation report is expected to be published by the end of 2018.

In broad terms, the legislation aimed to ensure availability of safe blood tissues and cells for EU citizens by defining clear lines of accountability both at service provider and health authority levels. The blood directive requires the use of CE marked assays in blood establishments and it also defines the minimum tests which need to be carried out on blood donations to ensure the safety and the quality of the blood supply.

The Commission has published a Roadmap on which stakeholders are invited to submit their comments until 15 February 2017.

2017 – Expected ‘Year of the IVD and MD Regulations’

2017 is likely to be the year of the IVD and MD Regulations. Legislators informed MedTech Europe to expect the publication of the IVD and medical device regulations sometime between the end of April and June 2017.

Updated texts have recently been agreed based on the revisions by legal-linguist services that fixed inconsistencies and typos.

The next step will be a series of political ‘legal’ votes expected to take place in Council and in the European Parliament between now and April 2017. The regulations are then expected to be published in the official journal between one to six weeks post-legal agreement. We are closely following the process to adopt the IVD and MD Regulations and will keep the industry updated on further developments.

Even after publication, more steps are expected to be done to complete a full legal framework. These critical steps include a number of secondary laws or ‘implementing acts’ that will be essential in setting up the basic infrastructure of the regulations. These will still need to be published early in the transition period. MedTech Europe is actively engaging across all our working groups to contribute to the development of secondary legislation as well as industry guidance.