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