Medical devices regulations to be adopted by Europe in May

Two proposed regulations on medical devices and in vitro diagnostic medical devices (IVDs) will be adopted by the European Commission by the end of May.

The regulations, which were endorsed by the Council of Ministers’ Permanent Representatives Committee and the European Parliament’s Environment Committee last year, will replace existing directives. The requirements of the regulations will apply three years after publication for medical devices and five years for IVDs.  

The medical devices regulation includes a 0.1% concentration limit for category 1A and 1B carcinogenic, mutagenic and reprotoxic (CMR) substances and endocrine disrupting chemicals (EDCs) in devices that are invasive and come into direct contact with the body, or (re)administer, transport or store medicines, body liquids or other substances, to and from the body.

Devices will be allowed to contain substances above the 0.1% concentration limit if justification is provided.

As part of the regulation, after a year the Commission will provide a mandate for the scientific committee to prepare guidelines of phthalates. This will include a benefit-risk assessment of their presence and the guidelines will need to be updated within five years.

Similar mandates will be issued for the preparation of guidelines on other CMRs.

Also included in the regulation are provisions on labelling, which require packaging devices to have labels indicating if their parts or materials contain a CMR or EDC above the concentration limit. A list of such substances must be included.

The regulations will be published in the Official Journal.