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EU Commission Extends MDR Transition Period for Certain Class 1 Devices

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745,...

EU Sets Limits on Formaldehyde used in Toy Materials

The Commission of the European Union (EU) has set limits for the use of...

A Tsunami of Regulatory Changes is Coming

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

EU Commission Updates Harmonized Standards List for Toys

The Commission of the European Union (EU) has published an updated list of harmonized...

EU Commission Clarifies Status of Substance Under REACH Regulation

The Commission of the European Union (EU) has clarified the exempt status of a...
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EU to Expand Lead Restrictions Under REACH

The European Union (EU) has announced its plans to expand the scope of lead...

Product Standards and Safety Marking, Post-Brexit

The United Kingdom’s House of Commons has released a briefing paper that addresses product...

EU Commission Updates REACH Restrictions

The Commission of the European Union (EU) has once again modified the restrictions on...

EU Commission Releases 2018 RAPEX Summary Statistics on Unsafe Consumer Products

The Commission of the European Union (EU) has released statistics on notices of unsafe,...

Notified Body in Spain Illustrates MDR Compliance Complexity

The Regulatory Affairs Professional Society (RAPS) is reporting that the Spanish Notified Body (NB)...
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