Expert Advice Community

Guest

Technical documentation of medical device class IIb

  Quote
Guest
Guest user Created:   Nov 18, 2021 Last commented:   Nov 19, 2021

Technical documentation of medical device class IIb

which are all the documental requirements I must give the notify body for can submit successfully a medical device class IIb that has a chanche of material? which are the principal points that you could give us as a tip to be more focus in order be correct a CEP, CER, RMP, RMR, BER.? What is the biggest tip that you can give me in order to know which laboratory test I must do to medical device? It´s possible that with scientific articles that talk about specific device I can substitute the laboratory test of medical device? which could be the legal base in order to can justify this?
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Nov 19, 2021
1. which are all the documental requirements I must give the notify body for can submit successfully a medical device class IIb that has a chanche of material? which are the principal points that you could give us as a tip to be more focus in order be correct a CEP, CER, RMP, RMR, BER.?

All documents required for technical documentation are presented in Annex 2 - Technical documentation and in Annex 3 Technical documentation for post-market surveillance of the MDR 2017/745.Considering the principal points for listed documents, they have to be in total with regulatory requirements. Notify bodies are very strict in auditing these documents, so everything that is requested has to be in documents. How this documentation looks like, you can see in our Documentation toolkit https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

These are the documents you will find in our toolkit for CER, CEP, RMR, and RMP:

More information regarding the content of technical documentation you can find on the following article:

2. What is the biggest tip that you can give me in order to know which laboratory test I must do to medical device?

Considering the biocompatibility, you have to go to the ISO 10993-1:2020  Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10), in Table 1 is presented which tests must be performed considering the type of the medical device: are they in the contact with intact skin, mucosae membrane, are they in breach or are they in contact with the blood, and how long are they in use on/in the human body.

Performance testing is something that are you need to decide considering what characteristic your medical device has (length, strength, volume, electrical testing, and so on).

3. It´s possible that with scientific articles that talk about specific device I can substitute the laboratory test of medical device? which could be the legal base in order to can justify this?"

For class IIb, it seems rather hard to justify with scientific literature laboratory testings. Medical devices class IIb are high-risk medical devices and it does not seem possible to make it with justification.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Nov 18, 2021

Nov 19, 2021