Regulation (EU) 2017/745 is not a frozen text. It explicitly empowers the European Commission to supplement, amend or clarify its provisions through delegated acts and implementing acts. These technical decisions change manufacturers’ obligations regarding classification, clinical evaluation, conformity and traceability. They are published in the Official Journal of the EU and enter into force on their own schedules, often without the media visibility they deserve.
For a manufacturer of class I to IIb medical devices, failing to track them means managing a technical file with an incomplete reference framework.
The three types of decisions to know
Delegated acts
Delegated acts amend or supplement non-essential elements of the MDR. The Commission adopts them under an empowerment granted by Parliament and the Council (Article 115 MDR). Concrete examples: amending the classification rules in Annex VIII, adjusting the list of implantable devices exempted from clinical investigations (Article 61(6)(b)), or extending the scope of Annex XVI to products without an intended medical purpose.
In March 2026, two delegated regulations illustrated this mechanism. Delegated Regulation (EU) 2026/1451 broadens the list of implantable and class III devices that may, under strict conditions, be exempted from the obligation to conduct clinical investigations. Delegated Regulation (EU) 2026/1359 extends the list of class IIb implantable devices for which the notified body is no longer required to assess the technical documentation of each device individually. These two texts concern well-established technologies (cannulas, catheters, dental implants, bone substitutes, pedicle screws, among others) and aim to make the MDR more proportionate without lowering the overall level of requirements.
A class IIb manufacturer whose portfolio includes this type of device should check whether its products appear in the broadened lists: the potential gain in terms of certification strategy and scheduling with the notified body is significant.
Implementing acts
Implementing acts specify the detailed arrangements for applying the MDR without amending its substantive elements. They cover operational areas: technical specifications for EUDAMED, UDI registration formats, lists of harmonised standards, uniform requirements for notified bodies (Implementing Regulation (EU) 2026/977).
Implementing Decision (EU) 2026/193 of 28 January 2026 updated the list of harmonised standards under the MDR by adding 12 new references, bringing the total to 48. Among them: EN ISO 14630:2024 (non-active surgical implants, general requirements), EN ISO 21535:2024 (implants for hip joint replacement), EN ISO 21536:2024 (implants for knee joint replacement). For manufacturers of orthopaedic implants, conformity with these standards triggers a presumption of conformity with the general safety and performance requirements of Annex I. Ignoring their publication means giving up a lever of evidence in the technical file.
Common specifications (Article 9 MDR)
Common specifications are a tool distinct from harmonised standards. The Commission adopts them by implementing acts when existing standards do not sufficiently cover an area, or when a public health concern requires it (Article 9 MDR).
Point of attention: to date, the common specifications adopted under Article 9 mainly concern Annex XVI products, that is, devices without an intended medical purpose (Implementing Regulation 2022/2346, amended by Regulation 2023/1194). These CS cover aesthetic implants, cosmetic contact lenses, liposuction equipment, brain stimulation devices, among others. They have applied since June 2023 for products that do not require a clinical investigation.
For devices with a medical purpose (medical breast implants, joint prostheses), the clinical and technical requirements fall under the standard conformity assessment procedures of the MDR (Annexes IX to XI), harmonised standards and, where applicable, consultation of the expert panels (Article 106). At this stage there are no specific common specifications adopted for these categories of medical devices under Article 9.
The MDR revision: proposal COM(2025) 1023
In December 2025, the Commission published a proposal for a targeted revision of the MDR and the IVDR. This text, currently under legislative review, provides for several structural changes: simplification of reclassification procedures for devices already on the market, adjustment of the classification rules for software (Rule 11 of Annex VIII), strengthening of cybersecurity obligations with notification to national CSIRTs and to ENISA, and modification of the link between the MDR and the AI Regulation (EU) 2024/1689.
For SME manufacturers of medical software, the proposal could result in a downgrade of certain devices currently in class IIa to class I, removing the obligation to involve a notified body. The impact on regulatory strategy and certification costs would be direct.
This text does not yet have the force of law. But waiting for its final publication to measure its consequences means falling behind on adapting your files.
What it changes for an SME manufacturer
Three questions to put to your quality manager right now. Do your devices appear in the broadened lists of Delegated Regulations 2026/1451 or 2026/1359? If so, your clinical evaluation strategy and your notified body schedule need recalibrating. Does your technical file reference the 12 new harmonised standards of Decision 2026/193, particularly for non-active implants? Conformity with these standards grounds a presumption of conformity: it strengthens the file before the notified body. Have you assessed the potential impact of proposal COM(2025) 1023 on the classification of your software devices?
Monthly monitoring of EUR-Lex and the Commission portal (health.ec.europa.eu) remains the most direct method for identifying these developments. But reading a regulation is not enough: each provision must be translated into concrete action in your QMS, your technical file and your PMS plan.
This is work that Thomas Trullen and Jonathan Bedin carry out systematically with the manufacturers they support in quality and regulatory affairs. Regulatory impact analysis is an integral part of every consulting engagement.
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Sources
- EUR-Lex — Official Journal of the EU
- European Commission — Medical devices — New regulations
- Implementing Decision (EU) 2026/193 — MDR harmonised standards