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.
A 2026 efficiency checklist: designation-scope matching, fee and lead-time criteria, RFQ preparation, and Regulation (EU) 2026/977.
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.
Official European Commission data on Notified Body backlogs, realistic certification timelines, and why manufacturers are narrowing their product portfolios.
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.
Which regulations require an AR, MDR/IVDR obligations, GPSR expansion, CH-REP vs UKRP, and how to evaluate AR service providers.
Complete compliance route for manufacturers outside the EU: CE marking, AR, importer obligations, EUDAMED, labelling, and country-specific notes.
Describe your product and compliance goal. ECP routes your request to Notified Bodies, certification bodies and testing labs that match your specific need.
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