Practical EU compliance explainers and checklists adapted for this website.
Regulatory news and changes
AFINA is the EU compliance marketplace connecting non-EU manufacturers with Notified Bodies, Authorized Representatives, Testing Laboratories, and Consultants.
Medical registration update
Locate relevant EU compliance paths
Interactive decision tree: do you need a Notified Body under MDR 2017/745 or IVDR 2017/746? 4 questions, definitive answer with regulatory basis.
Select your MDR or IVDR device class to see which Notified Bodies are designated and accepting applications. Filter by Class IIa, IIb, III, IVD B/C/D.
Find an accredited EMC testing laboratory for CE marking. AFINA matches your product and applicable standards to EMC labs with the right…
Find an accredited testing laboratory for RED 2014/53/EU compliance. AFINA matches your radio product to labs with the right RF, EMC and…
Representative roles and mandates
Representative requirement for non-EU manufacturers
Non-EU cosmetics brands need an EU Responsible Person under Cosmetics Regulation 1223/2009.
Non-EU companies selling consumer products in the EU need a GPSR Responsible Person from December 2024.
Decision aids and cost guides
Interactive decision tree: do you need a Notified Body under MDR 2017/745 or IVDR 2017/746? 4 questions, definitive answer with regulatory basis.
Guides and practical explainers
Medical device route overview
AFINA is the EU compliance marketplace connecting non-EU manufacturers with Notified Bodies, Authorized Representatives, Testing Laboratories, and Consultants.
Send the product details and we will suggest the next practical compliance step.