EC-MDR Information for manufacturers guidance

[dgrainger]

The EC has just (20/7/18) published some new guidance documents:

Regulatory framework - European Commission

Information for manufacturers

• Factsheet for manufacturers of medical devices
• Implementation model: medical devices
• Exhaustive list: requirements for medical devices manufacturers
• Factsheet for manufacturers of in-vitro diagnostic medical devices
• Implementation model: in-vitro diagnostic medical devices

 

[chris1price]

Interesting documents - thanks for posting.

One thing I was looking for, was any guidance on Combination Products; eg devices used to deliver medicines (inhalers, pre-filled syringes, etc). These are now linked to the MDR in Article 117. Has anyone seen any guidance on the requirements for these products?

Chris