ISO 13485 & EU MDR - Expert Advice Community

MDR 2017/745

I have my own company in ***. I buy glasses frames and sunglasses from a factory. The factory just send me a Declaration of Conformity of Optical Frames which says that they meet the MDR 2017/745. What does that mean for me? What do I have to do?

Procedure for Design documentation management for medical devices

Do you have separate procedure for "Design documentation management for medical devices"?  I mean how to execute drawings, Bill of materials, schemes electrical and so on? Thanks

CE Mark

We would like to inquire after regulations / requirements needed for a patient controlled analgesia pump. Is there a guideline that needs to be followed or adhered to in order to get the CE mark on a product?

Equipment Qualification vs. Process Qualification and Process Validation

I am trying to get a better understanding about the guidance on Equipment Qualification vs. Process Qualification and Process Validation. Can you refer me to the sections of the standard that speak about those topics?

Medical devices

Are medical devices subject to the falsified medicines directive (tamper proof and individual serialisation) or are you aware if this is the long term plan for them to meet this requirement?

https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features

Determining scope of certificate for company that outsources production processes

How do you determine the scope of a certificate for a company that outsources production processes?

Good Manufacturing Practice in pharmaceutical

We are looking for guidance with regards to Good Manufacturing Practice. Is this a certification that pharmaceutical companies need to apply for? How do they apply? If the company has ISO13485, can they use the GMP mark? or do they need to be registered for GMP?

Adverse Event Reporting

Hello

As a distributor of medical devices, if there is an adverse event, would I need to report it to the MHRA (we are UK based) or would that be the responsibility of the manufacturer?

thanks 

Specific requirement to provide After-Sales Service

I was wondering, according to MDSAP/ISO 13485 or Health Canada regulation, is there any specific requirement to provide After-Sales Service or spare parts for specific time (such as 10 years /20 years)?

Is technical file of device mandatory to put on device on market?

I was reading the full text of MDR, in this regard, if I have correctly understood: the technical file of the device is mandatory to be registered by an EU manufacturer or its representative. Once this is done in the EU country of the manufacturer or representative, the device can be put on the market in ALL  EU countries (not only the country where it was registered). Am I right?