CE marking is what allows you to sell a medical device or an in vitro diagnostic device (IVD) in the European Union. This guide explains, step by step, how to obtain it under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), and what Spain adds.
📌 In short
- ✍️ CE marking is affixed by the manufacturer, after assessing the conformity of its device.
- 📊 The risk class decides whether a notified body is needed.
- 🏢 In Spain you also need the AEMPS prior operating licence and registration in EUDAMED and RECOPS.
- 🗓️ Devices with certificates under the former Directives have deadlines up to 2027, 2028 or 2029, depending on the case.
🏷️ What CE marking is (and what it is not)
CE marking shows that the device complies with the MDR or the IVDR. It is not a “homologation” or an AEMPS certificate.
- ✍️ The manufacturer assesses conformity, signs the EU declaration of conformity and affixes the CE marking.
- 🔍 The notified body audits and certifies when the class requires it. The CE marking is then followed by its four-digit number.
- 🏛️ The AEMPS is the competent authority in Spain: it grants licences, monitors the market and inspects, but it does not affix the CE marking.
🔎 Step 0: is it a medical device or an IVD?
It is decided by the intended purpose declared by the manufacturer, not by the technology. The same formula can be a medical device, a biocide or a medicinal product depending on what it is marketed for.
- 💻 Software can also be a medical device: we explain it in our MDSW software service.
- ❓ If your product is borderline, define its intended purpose clearly before designing anything.
📊 Classification: do I need a notified body?
The MDR has 22 classification rules and the IVDR 7. The class decides the conformity assessment route.
Medical devices (MDR)
| Class | Notified body? | Assessment route |
|---|---|---|
| I | ❌ No: self-declaration | Technical documentation (Annexes II and III) and EU declaration of conformity |
| I sterile, with a measuring function or reusable instrument (Is, Im, Ir) | ⚠️ Only for those aspects | Annex IX (Chapters I and III) or Annex XI, Part A |
| IIa | ✅ Yes | Annex IX, or Annexes II and III plus Annex XI |
| IIb | ✅ Yes | Annex IX |
| III | ✅ Yes | Annex IX, or Annex X plus Annex XI |
In vitro diagnostics (IVDR)
| Class | Notified body? | Assessment route |
|---|---|---|
| A | ❌ No: self-declaration | Technical documentation and EU declaration of conformity |
| A sterile | ⚠️ Only for sterility | As set out in Article 48(10) |
| B | ✅ Yes | Annex IX |
| C | ✅ Yes | Annex IX, or Annex X plus Annex XI |
| D | ✅ Yes | Annex IX, or Annex X plus Annex XI |
🛠️ How to obtain CE marking in 8 steps
- 🧭 Regulatory strategy. Define the intended purpose, the class and the assessment route. This comes first, because it drives the design, the testing and the budget. → Product development
- 📋 Quality management system. Every manufacturer must have one, proportionate to the risk (Article 10(9) MDR and 10(8) IVDR). The reference standard is ISO 13485. → ISO 13485 certification
- ✏️ Controlled design and development. Risk management, usability and, if there is software, its life cycle.
- 🧪 Verification and validation. Safety and performance testing, biocompatibility or sterilisation, depending on the device. → Validations
- 🩺 Clinical or performance evaluation. For medical devices, based on sufficient clinical data (Article 61 MDR). For IVDs, on scientific validity and performance data (Article 56 IVDR).
- 📁 Technical documentation. The file that proves all of the above (Annexes II and III). → Technical file and QMS
- 🔍 Notified body. If the class requires it: application, audit and certificate. Spain has one: the AEMPS CNCps (0318), designated under both the MDR and the IVDR.
- ✅ Declaration of conformity and CE marking. Sign the EU declaration of conformity, affix the CE marking to the labelling and register the device in EUDAMED. → MD and IVD symbols and CE marking and EUDAMED registration guide
🔁 And afterwards: CE marking does not end with the certificate. You must keep up post-market surveillance, vigilance and, depending on the class, the periodic safety update report (PSUR):
| Class | PSUR |
|---|---|
| IIa | At least every two years |
| IIb and III | At least once a year |
| IVD classes C and D | At least once a year |
🏭 From prototype to series: the most underestimated part
The notified body does not only audit paperwork: it audits how the device is manufactured. If industrialisation is not solved, with critical suppliers qualified and processes validated, the audit becomes difficult. → Industrialisation and Supplier audits
🇪🇸 What Spain adds
- 🏛️ AEMPS: the competent authority for medical devices (Royal Decree 192/2023) and IVDs (Royal Decree 942/2025).
- 📄 Prior operating licence: required for anyone who manufactures, imports, groups or sterilises medical devices, and for anyone who manufactures, imports or sterilises IVDs. → AEMPS licences
- 🔤 Language: labelling and instructions for use must be at least in Spanish.
- 👤 Person responsible for regulatory compliance (PRRC): mandatory for the manufacturer. Micro and small enterprises may have this person outside their staff, provided they are permanently available.
- 🗂️ Registrations: EUDAMED (European) and RECOPS (Spanish). → EUDAMED registration guide
🗓️ Devices with certificates under the former Directives
“Legacy” devices can still be placed on the market for a time, if they meet the transitional conditions.
| Devices | Deadline |
|---|---|
| 🩹 MDR: class III and class IIb implantables | 31/12/2027 |
| 🩹 MDR: other IIb, IIa and sterile or measuring class I | 31/12/2028 |
| 🧪 IVD with a Directive certificate and class D | 31/12/2027 |
| 🧪 IVD class C | 31/12/2028 |
| 🧪 IVD class B and A sterile | 31/12/2029 |
⚠️ Conditions: having the quality system, having applied to the notified body and having signed the agreement with it by the dates each regulation sets. For medical devices those dates have already passed. For IVDs only those for class B and A sterile remain: application by 26/05/2027 and signed agreement by 26/09/2027.
🔮 What may change
In December 2025 the European Commission proposed simplifying the MDR and the IVDR [COM(2025) 1023]. Among other measures, it proposes to:
- remove the five-year limit on certificates;
- reduce how often the PSUR must be updated;
- lower the class of some devices, such as software;
- remove the need for a notified body for class A sterile IVDs.
⚠️ It is not law yet. As of November 2026 it is being debated in the European Parliament and the Council. Until it is published in the Official Journal, the MDR and the IVDR apply as they stand. We will report it in our news when it is adopted.
⏱️ How long does it take and how much does it cost?
There is no single figure: it depends on each device. What matters most is:
- 📊 The class and the assessment route, and above all whether a notified body is involved.
- 🩺 The clinical or performance data that must be generated.
- 🧪 The testing the device needs: electrical safety, biocompatibility, sterilisation…
- 📋 Whether a quality system is already in place.
- 🔍 The notified body’s availability and fees.
From 25/02/2027, Implementing Regulation (EU) 2026/977 sets common procedural requirements for all notified bodies.
At MeDev Consulting we give you a plan and a fixed quote for your case, phase by phase.
⚠️ Mistakes that delay CE marking
- ❌ Confusing CE marking with the AEMPS licence: they are different procedures and you need both.
- ❌ Classifying too low to avoid the notified body.
- ❌ Leaving the quality system until the end.
- ❌ Contacting the notified body late: there are few (as of 28/02/2026, 52 were designated under the MDR and 19 under the IVDR).
- ❌ Reaching the audit without validated manufacturing.
🤝 How MeDev Consulting helps
We are not an engineering firm that then looks for someone to certify the device, nor a consultancy that only tells you what to do: the same team develops, validates, documents and industrialises. We have done it, for example, with CRABCLAMP+, which holds an MDR CE certificate from the notified body BSI. See more cases in projects.
👉 Tell us about your device and we will tell you its class, the route that applies and how to reach CE marking.
❓ Frequently asked questions
Who grants CE marking? The manufacturer, after assessing conformity. If the class requires it, a notified body certifies first. The AEMPS does not grant it.
What does the number next to the CE mean? It is the number of the notified body involved. Self-declared devices (class I or class A IVDs) carry the CE without a number.
Is there a notified body in Spain? Yes: the National Centre for Medical Device Certification (CNCps, 0318), part of the AEMPS, designated under the MDR and the IVDR.
How long is a CE certificate valid? Today, five years at most. The simplification proposal would remove that limit, but it is not law yet.
What is the difference between CE marking and the AEMPS licence? CE marking belongs to the device. The prior operating licence belongs to the company and its premises (manufacturing, importing, sterilising). You need both.
Does an app need CE marking? Only if its purpose is medical. We explain it in our MDSW software service.
📚 Official sources
Last reviewed: 09/11/2026.
- Regulation (EU) 2017/745 (MDR), consolidated version
- Regulation (EU) 2017/746 (IVDR)
- Regulation (EU) 2023/607 and Regulation (EU) 2024/1860, on the transitional periods
- Simplification proposal COM(2025) 1023
- Royal Decree 192/2023 and Royal Decree 942/2025
- AEMPS: CNCps designated as notified body under the IVDR