Technical documentation of medical device class IIb

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:

• Clinical Evaluation Plan https://advisera.com/13485academy/documentation/clinical-evaluation-plan/
• Clinical Evaluation Report https://advisera.com/13485academy/documentation/clinical-evaluation-report/
• Risk Management Plan https://advisera.com/13485academy/documentation/risk-management-plan-iso-134852016/
• Risk Management Review https://advisera.com/13485academy/documentation/risk-management-review/
• EU MDR Annex 2 - Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex 3 - Technical documentation for post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/

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

• What are the EU MDR technical documentation structure and requirements? https://advisera.com/13485academy/blog/2021/04/06/what-are-the-eu-mdr-technical-documentation-structure-and-requirements/

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.