European Market (EU CE Marking)
Key Directive: Primarily falls under the
Medical Devices Regulation (MDR) if marketed for medical/therapeutic use.
Core Requirement: The manufacturer must prove the product meets essential safety and performance requirements. This involves a
technical documentation file and, for higher-risk classes, involvement of a
Notified Body (an independent certification organization).
Focus: Full quality assurance system and post-market surveillance.
UK Market (UKCA Marking)
Key Regulation: Follows the
UK Medical Devices Regulations 2002 (which largely mirrored the old EU directives, with updates).
Core Requirement: The manufacturer must declare the product conforms to UK regulations. For medical ice bags, this often means
self-declaration under the manufacturer's own responsibility. Involvement of a
UK Approved Body is less common for low-risk devices.
Focus: Based on the manufacturer's declaration of conformity to UK standards.
Key Difference for Manufacturers:
The primary difference lies in
regulatory oversight and recognition. For the EU, demonstrating compliance often requires independent verification (a Notified Body), especially for medical claims. For the UK, the manufacturer typically self-certifies compliance for low-risk products like ice bags, without mandatory third-party approval.
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