News in Brief

Commission clarifies non-recognition of UK organisations in future EU

UK organisations are about to disappear off the EU scene when it comes to medtech regulation and all stakeholders have only a little more than a year to make sure they are not involved in the possible outcome. This will … Continue reading

Posted on 27. April 2018

Deadline uncertainty caused over EU’s up-classified, low-risk products

Although efforts were made by the Transition Sub Group (TSG) of the Competent Authorities for Medical Devices (CAMD) to help industry comprehend the deadlines for CE marking its products under the new Medical Device and IVD Regulations, there is still … Continue reading

Posted on 22. April 2018

One UK notified body to be phased out this year as it moves to Sweden

Intertek has revealed that it submitted its application for notified body status under the EU Medical Devices Regulation to the Swedish Medical Products Agency in January 2018.

Posted on 17. April 2018

mdi Europa renews ISO certification

We successfully passed our ISO 9001:2015 audit and recently received our renewal certificate. Let us know if you require a copy.

Posted on 19. März 2018

Borderline products and classification: EU Commission set to review

Updating guidance documents on product classification and borderline drug/device products to indicate clearer the requirements of the new Medical Devices and IVD Regulations are among the priorities which the European Commission is expected to define for its medical device and … Continue reading

Posted on 16. März 2018

European Commission acts swiftly to avoid ‘non-medical’ product scandals

It is understood that the European commission is prioritising policies for regulating products in Annex XVI of the Medical Devices Regulation (MDR), usually spoken of as well-being or aesthetic products.

Posted on 13. März 2018

From our partner

Protective clothing – how BSI can help you to meet regulatory requirements

Posted on 10. März 2018

Updated lists of harmonised standards for medical devices and in-vitro diagnostic (IVD)

The European Commission has published updated lists of harmonised standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU).

Posted on 27. Februar 2018

Will EU Common Specifications interfere with International Standardisation?

Common Specifications already exist in the EU’S IVD Directive but using them to cover medical devices too is causing concern about how they might have an effect not only EU standards, but more importantly on international standards agreements.

Posted on 23. Februar 2018

Could manufacturers using UK notified bodies have post-Brexit difficulties?

There is some apprehension among manufacturers who have used one of the UK’s notified bodies to appraise the conformity of their medtech products against the medical device directives about the effects of Brexit on their products’ continued existence on the … Continue reading

Posted on 20. Februar 2018
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