Mdr 745 Specialist

What it does

This skill provides expert guidance on EU MDR 2017/745 compliance, covering medical device regulation requirements, technical documentation, clinical evidence, and post-market surveillance obligations. It specializes in classification and risk assessment, helping users determine the appropriate conformity assessment route for their medical devices. The skill offers a structured framework to guide these processes, referencing relevant MDCG guidance and considering borderline cases.

When to use it

• To determine the correct classification class (I, IIa, IIb, or III) of a medical device according to MDR Annex VIII.
• When selecting the appropriate conformity assessment route for a medical device.
• For assistance in preparing comprehensive technical documentation as required by Annex II and III of the MDR.
• To understand the implications of combination devices on classification.
• To prepare for consultation with a Notified Body regarding device classification.

Key capabilities

• Classification Decision Framework: Applies MDR Annex VIII rules to determine device classification.
• Risk Assessment Guidance: Provides expert guidance on risk assessment related to medical devices.
• Conformity Assessment Route Selection: Advises on selecting the appropriate route (self-certification, Module C2, Module B+C/D, or full quality assurance).
• Technical Documentation Structure: Outlines the structure of technical documentation required by Annex II & III.
• MDCG Guidance Consideration: Incorporates guidance from MDCG documents like MDCG 2019-11 for software classification.

Example prompts

• "What is the MDR classification for a device that [describe device characteristics]?"
• "Based on this description of my medical device, what conformity assessment route should I choose?"
• "Can you outline the required structure for technical documentation under Annex II of the MDR?"

Tips & gotchas

• This skill provides expert guidance but does not replace the need for consultation with a Notified Body.
• The classification process can be complex, especially for combination devices or borderline cases; careful consideration and documentation are essential.
• Referencing the references/mdr-classification-guide.md document is crucial for understanding the rationale behind classification decisions.