CE Marking Class 1 (Non sterile) medical device

[kramac]

Hi All,

We are a medical devices manufacturing startup and are in the process of setting up our manufacturing facility. Meantime we are using contract manufacturer who is having ISO 13485, FDA and CE mark for the product.

We are in the process of developing our own technical file and getting CE mark. We are the legal owner of the product. Product is surgical mask (non-sterile).

We have few questions.

1. Can we use contract manufacturer's test results (pre-clinical evaluation) of the product in our technical file documentation?
2. How do we link the contract manufacturer info into our technical document?
3. Can we mention the manufacturer's name and facility location in our technical file?
4. What is the next step after developing the technical document.

Hope you can help.

Thank you in advance.

 

[yodon]

I'll weigh in on questions 1 and 2. Hopefully others will pick up from there.

Ultimately, you're responsible for the test data. If they collected test data that complies with regulatory requirements and will share with you, I don't see a reason why you couldn't use their results.

Your CM is a providing a service which you purchase. You'll need to qualify and approve them as a supplier. Your qualification and approval should cover all aspects of services they provide (i.e., if they do your design verification and design validation testing, they should be assessed for suitability in doing so).

 

[kramac]

Hi Yondon, Thank you for feedback.

 

[renenatasha]

Hi All,

We are a medical devices manufacturing startup and are in the process of setting up our manufacturing facility. Meantime we are using contract manufacturer who is having ISO 13485, FDA and CE mark for the product.

We are in the process of developing our own technical file and getting CE mark. We are the legal owner of the product. Product is surgical mask (non-sterile).

We have few questions.

1. Can we use contract manufacturer's test results (pre-clinical evaluation) of the product in our technical file documentation?
2. How do we link the contract manufacturer info into our technical document?
3. Can we mention the manufacturer's name and facility location in our technical file?
4. What is the next step after developing the technical document.

Hope you can help.

Thank you in advance.

Good day, Kramac.

For Q3, if they are your critical supplier (involves in Design & Manufacturing), then you'll need to include that in your TF (esp. Part 3 of Annex II).
For Q4, refer to MDR 2017/745 Annex II and III for TF format.