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The proposed changes to the Medical Device Regulations have meant that the MEDDEVS guidance documents are now considered by MHRA to be mandatory requirements to demonstrate compliance with the Medical Devices Directive to meet regulatory requirements. Most Notified Bodies in the UK are already requiring full compliance with the relevant MEDDEVs.

The new medical device regulations are due later this year. If you have any concerns about your products in this area then contact Atlantic Bridge for advice and support.

Quality Standard BS EN ISO 13485:2012 only applies to the EU and any requirements outside the EU area may be on EN ISO13485:2003. This is fully acceptable for regulatory purposes. Device manufacturers in the EU may find their Notified Body certificates cover both standards.

For more information follow this link -