To ensure that medical devices certified by a UK Notified Body can still be imported into the Netherlands after a no-deal Brexit, an exemption procedure has been drawn up by the Dutch authorities. This exemption procedure is specifically drafted for a no-deal Brexit and the procedure only applies to the Netherlands and only for medical devices and in-vitro diagnostics, for reasons of the continuity of supply. An online application should be submitted and specific conditions and enforcement rules apply.

Application

An online application form should be completed by the manufacturer. In addition to the questions on the form, the following documents need to be submitted:

  • A certificate issued by a UK Notified Body.
  • A proof of application confirmed by a Notified Body from one of the 27 EU countries.
  • If available, a confirmed action plan with time lines for acquiring the new CE certificate

Conditions and requirements

In order to qualify for the exemption, certain conditions apply. This means –among other things– that the manufacturer has to declare that (i) the medical devices involved in the exemption are exclusively for Dutch healthcare providers who are currently already purchasing the medical device, (ii) an application for a new CE certificate is requested at an EU27 Notified Body before 29 March 2019, (iii) the healthcare providers are informed in writing about the exemption and its validity and (iv) it will maintain the current certified Quality Management System until it is re-certified by an EU27 Notified Body.

Furthermore, by applying for the exemption, the manufacturer agrees that certain information will be made public, including the:

  • Name manufacturer
  • Certificate(number)
  • Product category
  • Product
  • Article number
  • End date of the exemption

After the submission, the Dutch authorities may request further information in relation to started, ongoing or completed corrective and preventive actions following incidents in the past 36 months, or in relation the Post Marketing Surveillance (most recent report and management review). As soon as a new CE certificate is obtained, the Dutch authorities should be informed about this and the exemption will lapse immediately.

Timing

The Dutch authorities will inform manufactures after 12 April 2019 about whether the application has been granted.