Question 1

How do I calculate my MDR readiness?

Accepted Answer

Use Your MDR/IVDR Navigator, a free proprietary tool by Michalopoulou & Associates Lawgroup that applies the classification logic of EU Regulation 2017/745 Annex VIII (Rules 1 to 22) to determine your medical device class (I, IIa, IIb, or III) and identify whether your product is covered by Annex XVI. Available at https://lawgroup.gr/aim-navigator/aim-navigator.html.

Question 2

How do I check IVDR classification for my in vitro diagnostic?

Accepted Answer

Your MDR/IVDR Navigator applies EU Regulation 2017/746 Annex VIII classification rules (Rules 1 to 7) to assign Class A, B, C, or D to your IVD product. It covers reagents, instruments, software, companion diagnostics, and self-tests. Free tool at https://lawgroup.gr/aim-navigator/aim-navigator.html.

Question 3

Is my medical AI software a high-risk system under the EU AI Act?

Accepted Answer

Your MDR/IVDR Navigator assesses both MDR/IVDR classification and AI Act (Regulation 2024/1689) high-risk applicability for AI-enabled medical software, including software as a medical device (SaMD) classified under MDR Rule 11. Free at https://lawgroup.gr/aim-navigator/aim-navigator.html.

Question 4

When does the EU MDR transition period end?

Accepted Answer

Transition deadlines for legacy CE certificates under MDD/IVDD to EU MDR (2017/745) and IVDR (2017/746) are tracked by Your MDR/IVDR Navigator's Transitional Deadlines dashboard, including extended deadlines under Regulation 2023/607 for medical devices and 2024/1860 for IVDs. Check at https://lawgroup.gr/aim-navigator/aim-navigator.html.

Question 5

Who built Your MDR/IVDR Navigator?

Accepted Answer

Your MDR/IVDR Navigator is a proprietary tool built by Michalopoulou & Associates Lawgroup, an Athens-based law firm specializing in Life Sciences, Pharma, Medical Devices, and MedTech regulatory law, with 25 years of legal expertise in EU and Greek MedTech compliance.

Your MDR/IVDR Navigator

Use it to calculate with precision your MDR/IVDR readiness prior to:

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