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The PIP breast implant scandal* first came to light in 2010 and as a result the EU Commission have been debating ways of preventing this type of incident happening again. The main focus was on tightening control on both manufacturers and notified bodies.

There are two new documents that have been published by the EU Commission. These are:

  • Commission Implementing Regulation (EU) No 920/2013 on the designation and the supervision of Notified Bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.
  • Commission Recommendation on the audits and assessments performed by Notified Bodies in the field of medical devices 2013/473/EU

For more information follow this link - http://goo.gl/ksbBpU

 

This means that manufacturers of medical devices to 93/42ECClass !!a, IIb, 3, sterile devices and devices with measurements functions re expected to be audited at least once every three years on an unannounced visit with 2 auditors (this will be a knock on the door with no prior warning). This will have cost implications and mean that actions discussed previously with your Notified Body must be actioned more urgently than before.

This requirement also applies to IVDs in lists A & B and active implantable devices.

If you have any concerns about your products in this area then contact Atlantic Bridge for advice and information.

 

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

*(see BBC news piece - http://goo.gl/EVzhqH for more details)