Updated July 2026. Scope: EU MDR 2017/745 and IVDR 2017/746, the competent authority. For the short definition, see the competent authority glossary entry.
Key takeaways
- A competent authority is the national government body each EU Member State designates to implement and enforce the medical device rules (MDR Article 101).
- It is not the same as a notified body. The competent authority is a public regulator; a notified body is a private organisation the competent authority designates and monitors.
- Competent authorities run market surveillance, vigilance, registration oversight, and enforcement in their country, and they oversee the notified bodies based there.
- There is one system, many authorities. Each Member State has its own, coordinated through the Medical Device Coordination Group (MDCG).
What a competent authority is
Under MDR Article 101, each Member State must “designate the competent authority or authorities responsible for the implementation of this Regulation,” and must give them “the powers, resources, equipment and knowledge necessary for the proper performance of their tasks.” The Member States inform the European Commission, which publishes the list.
In plain terms, the competent authority is the national medical device regulator. In Germany it is a different body than in France or the Netherlands, but each plays the same role under the same Regulation within its territory.
What a competent authority does
The competent authority is the public enforcer of the device rules in its country. Its work spans:
- Notified body oversight. Designating and monitoring the notified bodies established in its territory, and acting when a notified body falls short.
- Market surveillance. Checking devices on the market, and taking action against non-compliant or unsafe devices.
- Vigilance. Receiving and assessing serious incident and field safety corrective action reports, and coordinating responses.
- Registration and oversight. Overseeing the registration of economic operators and devices, increasingly through EUDAMED.
- Enforcement. Using its national powers to restrict, withdraw, or recall devices, and to sanction non-compliance.
Competent authority versus notified body
This is the distinction that trips people up most. The two are not interchangeable:
| Competent authority | Notified body | |
|---|---|---|
| What it is | A national public regulator | A private conformity-assessment organisation |
| Where it comes from | Designated by a Member State (MDR Article 101) | Designated and monitored by a competent authority |
| Main role | Oversight, market surveillance, vigilance, enforcement | Assessing whether a manufacturer’s device and QMS meet the requirements, and issuing certificates |
| Relationship to the manufacturer | The regulator over the market | The body a manufacturer engages for conformity assessment |
A notified body issues your CE certificate; a competent authority stands behind the whole system and can act on the market. Assuming your notified body is the regulator, or that the competent authority certifies your device, gets the relationship backwards.
Frequently asked questions
What is a competent authority in the EU MDR?
The national authority each Member State designates to implement and enforce the MDR in its territory (MDR Article 101), covering notified body oversight, market surveillance, vigilance, registration, and enforcement.
Is a competent authority the same as a notified body?
No. A competent authority is a public national regulator. A notified body is a private organisation that carries out conformity assessments and issues certificates, and which the competent authority designates and monitors.
Is there one competent authority for the whole EU?
No. Each Member State designates its own competent authority or authorities. They work under the same Regulation and coordinate through the Medical Device Coordination Group (MDCG), but each acts within its own country.
Does the competent authority approve or certify my device?
No. Conformity assessment and certification, where a notified body is required, are done by the notified body. The competent authority oversees the system, the market, and the notified bodies, rather than certifying individual devices.
Related guides and services
- Regulatory Affairs support from CENIT Consulting: navigating competent authorities, notified bodies, and the MDR/IVDR obligations that connect them.
- For EU representation and the compliance role, see PRRC services and the competent authority glossary entry.
This article is for general information only and is not legal or regulatory advice. Teams remain responsible for regulatory decisions and staying current with applicable regulations and guidance.
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