CE Marking and EU MDR/IVDR Strategy
CE marking is the outcome of demonstrating that your device conforms to the General Safety and Performance Requirements of the EU MDR (2017/745) or IVDR (2017/746). The path to it depends on how your device is classified and which conformity assessment route that triggers, and getting the strategy right at the start saves months later. EvySaif shapes the regulatory strategy and prepares the documentation that carry a device toward CE marking.
Classification drives everything
Under the MDR, medical devices are classified as Class I, IIa, IIb, or III based on Annex VIII rules, while under the IVDR, in vitro diagnostics are classified as Class A, B, C, or D. Classification determines the conformity assessment route, the depth of evidence required, and whether a Notified Body must be involved. An error here reshapes the entire project.
Classify and justify
Choosing and justifying the correct classification is the first strategic decision. Lower-risk products (Class I non-sterile devices, Class A non-sterile IVDs) can generally self-certify; everything above requires Notified Body assessment of the technical documentation and, for many, the quality management system.
Plan the route
A well-planned route brings together the technical documentation, the clinical or performance evaluation, a quality management system (typically ISO 13485), the Declaration of Conformity, UDI assignment, and registration in EUDAMED.
Set up EU roles
Manufacturers outside the EU must appoint an EU authorised representative, and every manufacturer needs a person responsible for regulatory compliance (PRRC).
Submit and transition
We prepare the documentation a Notified Body will assess and support you through their questions. For products transitioning from the old Directives, we plan the move from MDD or IVDD, including the reclassification that has pulled many previously self-certified products into Notified Body oversight.
Where we fit: we prepare the strategy and documentation and work alongside your Notified Body and quality functions. We do not issue certification or run the audit, which keeps our role clear and your submission clean.
What we prepare
Strategy and classificationRegulatory strategy and classification rationale under MDR and IVDR.
Conformity routingConformity assessment route planning.
GSPR gap analysisGSPR gap analysis and evidence planning.
Documentation preparationTechnical documentation and clinical or performance evaluation.
Notified Body supportSubmission support and responses to assessment questions.
Transition planningGuidance on authorised representative, PRRC, UDI, EUDAMED, and MDD/IVDD transitions.
How EvySaif helps
We shape the regulatory strategy and prepare the documentation that carry a device toward CE marking. We classify and justify, plan the conformity route, close GSPR gaps, and support you through Notified Body assessment, transitions included.
Why EvySaif
As one of the best research and medical writing consultancies in India, EvySaif pairs regulatory strategy with the ability to build the evidence underneath it, so the plan is grounded in what can actually be delivered. We prepare the strategy and documentation and work alongside your Notified Body and quality functions; we do not issue certification or run the audit, which keeps our role clear and your submission clean.
Frequently asked questions
Yes. Classification determines the conformity assessment route, the evidence required, and whether a Notified Body is involved, so it is the first and most consequential decision.
No. Notified Bodies are independent conformity assessment bodies. We prepare your strategy and documentation and support you through their review; we do not assess or certify.
Yes. We plan the transition, including reclassification and the additional documentation the current Regulations require.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalPlanning your route to CE marking?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal