--- title: The Role of the European Commission in MDR Implementation description: The European Commission shapes MDR implementation through EUDAMED, common specifications, harmonized standards, and implementing acts — here is what startups need to know. authors: Tibor Zechmeister, Felix Lenhard category: MDR Fundamentals & Regulatory Strategy primary_keyword: canonical_url: https://zechmeister-solutions.com/en/blog/european-commission-mdr source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # The Role of the European Commission in MDR Implementation *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* The European Commission wrote the MDR. But its role did not end with adoption. The Commission continues to shape how the regulation is implemented, interpreted, and evolved — through EUDAMED management, common specifications, harmonized standards, implementing acts, and coordination with member states. For startups, Commission decisions affect your compliance requirements, your timelines, and the practical landscape of MDR implementation. Here is what the Commission does and why it matters for your startup. ## What Is the Commission's Ongoing Role Under the MDR? The MDR delegates specific powers to the Commission. These include: **Adopting implementing acts and delegated acts.** The MDR authorizes the Commission to adopt supplementary rules on topics including UDI system details (Article 27), EUDAMED specifications (Article 33), reclassification of devices (Article 51(3)), and common specifications (Article 9) . These acts add detail to the regulation and can create new requirements that did not exist in the original text. **Managing EUDAMED.** The European Database on Medical Devices is a Commission-managed system. The Commission determines when EUDAMED is fully functional (Article 34) , which triggers obligations that are currently dormant because EUDAMED is not yet fully operational. **Requesting harmonized standards.** The Commission mandates European standardization organizations to develop harmonized standards under the MDR and publishes the official list of standards that create a presumption of conformity. **Coordinating market surveillance.** Through the MDCG and direct coordination mechanisms, the Commission facilitates cooperation between national competent authorities on market surveillance matters. **Adopting common specifications.** Article 9 gives the Commission the power to adopt common specifications where no harmonized standard exists or where existing standards are insufficient . Common specifications, once adopted, become mandatory unless the manufacturer can demonstrate compliance through an alternative means that provides an equivalent level of safety and performance. ## How Do Common Specifications Affect Startups? Common specifications are the Commission's tool for setting specific technical requirements for device categories where harmonized standards are lacking. Unlike harmonized standards — which provide a voluntary "presumption of conformity" — common specifications have a different legal weight. When the Commission adopts common specifications for your device category, you must either: 1. Comply with the common specifications, or 2. Demonstrate that your alternative approach achieves at least an equivalent level of safety and performance For startups, monitoring the Commission's common specification activity is important because new common specifications can create new requirements mid-development. If the Commission adopts common specifications for Annex XVI devices (products without intended medical purpose) while you are developing such a product, your compliance requirements change. The Commission has been working on common specifications for Annex XVI product groups, including aesthetic devices and non-medical implants . ## What Is EUDAMED and Where Does It Stand? EUDAMED is intended to be the central IT platform for the MDR ecosystem, containing: - **Actor registration module:** Registration of manufacturers, authorized representatives, importers - **UDI/Device registration module:** Registration of devices and their UDI data - **Notified Body and certificates module:** Records of Notified Body designations and issued certificates - **Clinical investigations module:** Registration and tracking of clinical investigations - **Vigilance module:** Reporting and tracking of serious incidents and field safety corrective actions - **Market surveillance module:** Coordination of market surveillance activities The original plan was for EUDAMED to be fully functional by the MDR's date of application (May 26, 2021). That did not happen. Modules have been deployed incrementally, with the actor registration module available since late 2020 . Until the Commission formally confirms that EUDAMED is fully functional, certain MDR provisions that depend on EUDAMED do not apply. Instead, equivalent obligations are fulfilled through national systems. Once full functionality is confirmed, there will be a transition period for manufacturers to migrate to EUDAMED . For startups, the practical impact is: - Register in the currently available EUDAMED modules where possible - Also register in the national systems of the member states where you sell - Build your IT systems with EUDAMED integration in mind — full deployment will eventually happen - Monitor Commission announcements about EUDAMED functionality ## How Do Harmonized Standards Get Published? The process works as follows: 1. The Commission identifies a need for a harmonized standard and issues a standardization request to the relevant European standardization organizations (CEN, CENELEC, ETSI) 2. The standardization organization develops or adopts the standard (often based on international standards like ISO or IEC standards) 3. The standard is submitted to the Commission for review 4. If the Commission determines the standard adequately covers the relevant MDR requirements, it publishes the standard reference in the Official Journal of the European Union 5. From the date of publication, applying the standard creates a "presumption of conformity" with the corresponding MDR requirements The list of harmonized standards under the MDR has been slower to develop than anticipated. Under the MDD, there was a well-established list. Under the MDR, many standards needed to be updated or new ones developed to align with the changed requirements. As of 2026, the list is growing but still incomplete . For startups, this means: - Check the current list of harmonized standards before selecting which standards to apply - If a standard you rely on is not yet harmonized under the MDR, you can still use it — but it does not create a presumption of conformity. You will need to demonstrate compliance through other means. - Monitor updates to the harmonized standards list. New harmonizations can simplify your compliance path; withdrawn harmonizations can complicate it. See [Harmonized Standards Under MDR: The Complete List for 2026](/blog/038-harmonized-standards-2026) for the current listing. ## What About the MDR Amendment Process? The Commission can propose amendments to the MDR through the ordinary legislative procedure (requiring European Parliament and Council approval) or, for certain provisions, through delegated and implementing acts. The most significant amendment to date is Regulation (EU) 2023/607, which extended the transition periods for legacy devices. This amendment was adopted in response to the Notified Body bottleneck and the risk of device shortages — it was a pragmatic recognition that the original timeline was not achievable. Future amendments are possible, particularly in areas like: - AI and machine learning medical devices (alignment with the EU AI Act) - Digital health and telemedicine devices - Further transition period adjustments if capacity constraints persist - EUDAMED-related provisions as the system evolves For startups, the key message is: the MDR is a living document. While the core requirements are stable, the implementing details, transition periods, and supplementary rules continue to evolve. Stay current with Commission publications, MDCG guidance, and industry updates. ## Practical Impact for Startups The Commission's activities affect startups primarily through: 1. **Timing of EUDAMED.** Full EUDAMED functionality will create new registration and reporting obligations. Plan for this. 2. **Common specifications.** New common specifications can create new requirements for your device category. Monitor these. 3. **Harmonized standards.** The availability (or absence) of harmonized standards affects how you demonstrate conformity. Track the list. 4. **Policy direction.** The Commission's policy priorities — digital health, AI regulation, health technology assessment — signal where future regulatory changes will focus. The Commission does not audit you. It does not issue your certificate. It does not inspect your premises. But its decisions shape the regulatory environment in which every other interaction takes place. Next: [MDR Article 5: Placing on the Market and Putting into Service — What Startups Need to Know](/blog/019-mdr-article-5-placing-on-market). --- *This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*