The REGULATORY Room

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The European Commission published its proposal to amend MDR and IVDR, aiming for roughly 30 percent less administrative burden. In July, the European Parliament's rapporteur published a draft report proposing over 130 changes to that proposal. Negotiations continue through autumn.

For RA and QM teams this creates an awkward situation. You cannot plan against a moving target, but you also cannot afford to wait for the final text.

This Regulatory Room session tackles exactly this. Michael Kania and Dr. Bassil Akra will separate what is likely to survive the legislative process from what is still up in the air, and cover the preparation that makes sense now regardless of the outcome.