CE Marking Consultants for EU MDR and IVDR Compliance

CE marking under the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 is the legal gateway to the European Economic Area. Medfins International helps manufacturers in India and overseas classify their devices, build compliant technical documentation, prepare for notified body review and meet EUDAMED, vigilance and post-market obligations.

What is CE marking for medical devices?

CE marking is the manufacturer’s declaration that a medical device or IVD meets the General Safety and Performance Requirements (GSPR) of the applicable EU regulation. For medical devices the legal basis is Regulation (EU) 2017/745 (EU MDR); for in vitro diagnostics it is Regulation (EU) 2017/746 (IVDR). Once affixed, the CE mark allows the product to circulate across all EU member states and the wider EEA.

Except for the lowest-risk products, CE marking requires an assessment by an EU notified body. The notified body audits your quality management system and reviews technical documentation before issuing a certificate, after which you sign an EU Declaration of Conformity.

Who needs CE marking?

• Manufacturers placing devices on the EU market under their own name, including Indian exporters and contract manufacturers who act as legal manufacturer.
• Non-EU manufacturers, who must also designate an EU Authorised Representative established in the EU under a written mandate (Article 11 MDR / IVDR).
• Legacy device holders still selling under MDD, AIMDD or IVDD certificates who must complete transition to MDR or IVDR within the extended deadlines.
• Companies seeking CE marking as a reference approval for other markets, such as the Gulf, Egypt and several ASEAN countries.

Classification under MDR and IVDR

Under the MDR, devices fall into Class I (including sterile, measuring and reusable surgical sub-categories), IIa, IIb and III, using the 22 rules in Annex VIII. Under the IVDR, IVDs are classified A, B, C or D using the seven rules in Annex VIII. Classification decides the conformity assessment route and how deeply the notified body is involved.

Only Class I (non-sterile, non-measuring, non-reusable surgical) devices and non-sterile Class A IVDs can be self-certified. Everything else needs a notified body certificate.

Transition deadlines you should know

EU MDR (Regulation (EU) 2023/607)

Legacy devices with valid MDD/AIMDD certificates may remain on the market until 31 December 2027 (Class III and Class IIb implantables, with some exceptions) or 31 December 2028 (other Class IIb, Class IIa and Class I sterile or measuring devices). This is conditional: an MDR-compliant QMS, a formal application to a notified body lodged by 26 May 2024 and a signed written agreement by 26 September 2024, with no significant changes to the device.

IVDR (Regulation (EU) 2024/1860)

Regulation 2024/1860 extended IVDR transition periods to 31 December 2027 for Class D, 31 December 2028 for Class C and 31 December 2029 for Class B and sterile Class A devices, provided the manufacturer meets staged conditions on QMS, notified body applications and written agreements. It also introduced a duty (Article 10a) to inform authorities in advance of an interruption or discontinuation of supply of certain devices.

EUDAMED

Following the Commission notice published in November 2025, the first four EUDAMED modules (actor registration, UDI/device registration, notified bodies and certificates, and market surveillance) became mandatory from 28 May 2026, with transitional provisions for devices already on the market. Manufacturers should confirm their Single Registration Number (SRN) and UDI data are complete.

The European Commission has also proposed a targeted revision of the MDR and IVDR to simplify certain requirements. Until any amendment is adopted and published, the current rules apply, and we track developments for our clients.

Documents required

• Device description, intended purpose, variants and accessories.
• Technical documentation per Annexes II and III (post-market surveillance).
• GSPR checklist with applied harmonised standards and common specifications.
• Risk management file to ISO 14971 and usability evidence to IEC 62366-1.
• Clinical evaluation report (MDR) or performance evaluation report (IVDR), with PMCF / PMPF plans.
• Verification and validation: biocompatibility, electrical safety, software (IEC 62304), sterilisation, shelf life.
• ISO 13485:2016 QMS aligned with Article 10 obligations, including a Person Responsible for Regulatory Compliance (PRRC).
• Labelling, IFU, UDI assignment and EU Declaration of Conformity.

CE marking process: step by step

1. Gap assessment of the product, existing files and QMS against MDR or IVDR.
2. Classification and route selection, including the correct Annex for conformity assessment.
3. QMS upgrade to ISO 13485 plus MDR/IVDR-specific processes (PMS, vigilance, PRRC, UDI).
4. Technical documentation and clinical or performance evidence compiled and reviewed.
5. EU Authorised Representative appointed under a written mandate for non-EU manufacturers.
6. Notified body application, audit and technical documentation assessment, with responses to non-conformities.
7. Certificate issue, EU Declaration of Conformity, CE mark affixed and EUDAMED registration.
8. Post-market surveillance, PSUR or PMS report, vigilance and annual surveillance audits.

Timelines and what affects them

There is no fixed statutory timeline for notified body review. In practice the duration depends on notified body capacity, device class, the maturity of your clinical or performance evidence and how quickly non-conformities are closed. Class III, implantable and Class D projects typically take longest because of additional scrutiny procedures. Starting early and submitting a complete, well-indexed file is the single biggest factor you control.

Common reasons for delays and queries

• Clinical evaluation relying on equivalence that cannot be justified under MDR rules.
• GSPR checklists that list standards without linking to objective evidence.
• Risk management not traced through design, labelling and PMS.
• Outdated standards versions or missing software lifecycle documentation.
• Incomplete PMCF plans and weak post-market surveillance procedures.

How Medfins International supports your CE marking

Our team, led by a CQI and IRCA certified ISO 13485 Lead Auditor, works as an extension of your regulatory function. We carry out gap assessments, write and review technical documentation, prepare clinical and performance evaluation inputs, and coordinate with your chosen notified body and EU Authorised Representative until certification.

Many clients combine CE marking with ISO 13485:2016 certification and MDSAP so one QMS supports multiple markets. For ongoing PMS and vigilance work, our annual maintenance contract keeps your files current. Contact us to discuss your device and transition plan.

Frequently asked questions