⏳ If your device was self-declared and is class C today, this concerns you.
🔑 The filter, in one sentence. Under Directive 98/79/EC, only Annex II devices (Lists A and B) and self-testing devices (design examination, Annex III.6) went through a Notified Body. Everything else was self-certified under Annex III. That is why the ones truly affected by this date are the class C devices that were never in Annex II: rubella, toxoplasmosis, CMV, Chlamydia, PSA or phenylketonuria already had an NB. Troponin, INR or tacrolimus did not. They have never worked with a Notified Body and now they have to, on a timeline that is already running.
📅 26 September 2026 — deadline to have the written agreement with your NB signed. Having lodged the formal application by last 26 May is not enough: the contract must be signed.
⚠️ What is at stake: the signed agreement is what lets you keep placing the device on the market under Directive 98/79/EC until 31 December 2028. Without it, the transitional period no longer applies and you cannot place a single further unit on the market until you obtain the IVDR certificate.
📋 And it is not the only condition of Article 110. You must also maintain:
✅ A QMS compliant with Article 10(8) (enforceable since 26 May 2025)
✅ Continued compliance with Directive 98/79/EC
✅ No significant changes to the design or intended purpose
✅ No unacceptable risk to patients or users
🔎 Class B, or class A sterile? Your timeline: 26 May 2027 (application), 26 September 2027 (contract), 31 December 2029 (end of transition). Notified Body capacity is limited: do not leave it for the last quarter.
📌 At Medev Consulting we support the whole process: eligibility analysis, classification, technical documentation, liaison with the NB and follow-up through to certification.
📩 Shall we talk? https://www.medev.es/en/contacto/