EU AI Act Essentials for SaMD: What You Need to Know Before You Launch | Freyr - Global Regulatory Solutions and Services Company

What is it all about?

Key discussion points include:

EU AI Act and its relevance for SaMD
Risk-based classification and required documentation
Conformity assessment and regulatory strategy
Software-first certification approach by Scarlet
Actionable steps for proactive compliance

Freyr continues to host focused fireside chats on regulatory trends in life sciences. We look forward to welcoming you to our upcoming sessions.

Shilpa Gampa

Head- Medical Devices Delivery & Practice, Freyr

Shilpa Gampa is a Regulatory affairs strategist with expertise in FDA submissions, SaMD (Software as a Medical Device) Regulatory compliance, and C-level executive consultation for developing go-to-market strategies. She is acting as the regional delivery head for America’s clients at Freyr in her primary role for global market submissions, with a focus on innovations and Regulatory strategies for medical devices and SaMD.

Dr Camille Petri

Clinical Evidence, AI & Regulatory Specialist, Scarlet

Dr Camille Petri is a Clinical Evidence, AI & Regulatory Specialist at Scarlet. He has extensive expertise in the development, evaluation, and integration of AI & ML into healthcare and medical devices. He holds master’s degrees in Applied Mathematics, Public Health, and Artificial Intelligence, as well as an MD with a specialisation in Public Health. Dr Petri’s work bridges the technical and clinical aspects of healthcare, covering regulatory submissions of AI medical devices, clinical evidence evaluation, and the analysis of AI models. His unique combination of medical, public health, and AI expertise makes him a leading voice in the future of AI-driven healthcare, particularly in the context of upcoming regulations such as the EU AI Act.

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Medical Devices Regulatory Services

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What is it all about?

Shilpa Gampa

Dr Camille Petri

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