Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products
Executive Summary
At last, common specifications for different groups of products that do not have an intended medical purpose but are covered in the scope of the EU’s Medical Device Regulation, are on the way.
You may also be interested in...
EN ISO 13485 And Symbols Standards Harmonized Under EU's IVDR
The European version of the international risk management standard, EN ISO 14971:2019, may have slipped through the net this January, but the European Commission has just published five new standards harmonized under the IVD Regulation.
Notified Body Training Session Highlights Need For More Support For SMEs
The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.
25% increase in Demand For Notified Bodies To Assess Annex XVI Non-Medical Products
The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?