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Medical Device Consultant.MY
EU MDR 2017/745 · Notified body route

CE marking for Malaysian manufacturers — engineered, not improvised.

The EU is a demanding market with the world's most detailed device regulation. We take your existing technical core, upgrade it to MDR Annex II/III depth, and manage the notified body process to the CE certificate.

Technical file service
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
Scope

What a CE engagement covers

CE marking under EU MDR 2017/745 is a system, not a stamp: a classification decision, a conformity assessment route, technical documentation to Annex II/III, a quality system (usually ISO 13485), clinical evaluation, and the EU-side infrastructure — authorized representative, importer, PRRC and EUDAMED/UDI registration. Missing any one of them stalls the rest.

We run the program end to end from Malaysia, coordinating the EU-side actors for you. Where we already hold your MDA dossier, the CE file inherits its engineering core — you pay for the MDR delta, not a second documentation project.

Workstreams

  • MDR classification and conformity assessment route selection
  • Technical documentation build/upgrade to Annex II & III
  • Clinical evaluation report to MDR expectations
  • Notified body selection, application and query management
  • EU authorized representative & importer coordination; PRRC requirement
  • UDI assignment and EUDAMED registration
  • MDR-grade post-market surveillance plan (pairs with our PMS retainer)

CE projects are quoted per device family after a technical file review — MDR effort varies enormously by class and clinical evidence. The review itself is fast: send your document inventory and target class on WhatsApp.

FAQ

Frequently asked questions

What changed from the old MDD to EU MDR?
EU MDR 2017/745 raised the bar across the board: stricter clinical evidence expectations, deeper technical documentation (Annexes II and III), mandatory UDI, registration in EUDAMED, a named person responsible for regulatory compliance (PRRC), and tighter post-market surveillance. Files that sailed under MDD routinely fail MDR review — plan for an upgrade, not a re-badge.
Does my Malaysian company need an EU presence?
A manufacturer outside the EU must appoint an EU authorized representative (EC REP) and have an importer within the EU. We coordinate the EU AR appointment as part of the engagement — the mirror image of the AR service we provide to foreign manufacturers entering Malaysia.
Which devices need a notified body?
All classes above Class I (and some Class I: sterile, measuring, reusable surgical) require conformity assessment by a notified body. Notified body capacity is a real bottleneck — securing a slot early is often the critical-path item, and we plan the submission calendar around it.
Can you reuse our MDA registration documents for CE?
Substantially. If we built your CSDT dossier, the engineering core (design specs, risk file per ISO 14971, verification evidence, clinical evaluation) transfers into MDR Annex II/III structure with targeted upgrades — usually clinical evidence depth and PMS documentation. That reuse is the whole point of building the file properly at stage one.
How long does CE marking take?
Realistically a year or more for devices requiring notified body review, driven by documentation readiness, clinical evidence and notified body queue times. Class I self-declared devices are much faster. We give a device-specific timeline after reviewing your technical file.

Europe on the roadmap?

Send us your device class and current documentation status. We will map the MDR route, the notified body question and a realistic timeline.

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