Economic Operators: New Responsibilities & How To Manage Them
The new EU MDR rules for economic operators are complex and burdensome for those not used to them. Chad Reynolds of RMQ+ outlines practical strategies for managing economic operators efficiently, and with a view to long-term compliance.
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The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.
There are very few regulatory hurdles to placing a COVID-19 test on the EU market under the IVD Directive. This situation, however, is changing under the IVD Regulation. The European Commission explains what manufacturers need to weigh up when deciding their regulatory pathway.
When Will A Notified Body Conduct An MDR/IVDR Virtual Audit And How? BSI Netherlands Gives Its Views
When it comes to notified bodies deciding whether to undertake virtual audits or not in the context of the new EU medtech regulations, there are many elements that need considering and many different potential responses and cost implications. In this interview, BSI Netherlands explains its approach.