European
Compliance Platform
European
Compliance Platform
Practical, in-depth guides for manufacturers, exporters, and compliance teams navigating EU market access — from CE marking basics to MDR, IVDR, and authorized representative obligations.
Which directive applies, conformity assessment routes, technical documentation, Declaration of Conformity, and typical costs and timelines.
What goes in the technical file, MDR Annex II requirements, GSPR checklist, risk management, and common mistakes to avoid.
NANDO database, scope of designation, MDR capacity issues, pre-submission meetings, and key questions to ask before applying.
Expanded high-risk categories, cybersecurity requirements, digital instructions, and how to prepare before the 2027 application date.
Who must appoint an AR, what they do, label requirements, how to choose the right AR, and mandate agreement essentials.
The six product groups with no medical purpose covered by MDR Annex XVI: fillers, lasers, implants, fat reduction, and compliance obligations.
EUDAMED mandatory phases, SRN registration, UDI device database, NB certificate registration, and the complete action checklist for MDR/IVDR manufacturers.
What ISO 13485 certification covers, what MDR adds on top, combined Notified Body audits, and typical costs and timelines.
General Product Safety Regulation scope, EU Responsible Person requirement, technical documentation, Safety Gate reporting, and penalties.
SVHC and SCIP obligations, REACH Only Representative, RoHS restricted substances, and how the two regulations interact.
Complete compliance route for manufacturers outside the EU: CE marking, AR, importer obligations, EUDAMED, labelling, and country-specific notes.
Which regulations require an AR, MDR/IVDR obligations, GPSR expansion, CH-REP vs UKRP, and how to evaluate AR service providers.
Concise overview of the EU compliance system for non-EU manufacturers: the three pillars, regulatory categories, and building your compliance team.
Describe your product and compliance goal. ECP routes your request to providers — EU ARs, Notified Bodies, testing labs, and consultants — who match your specific need.
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