Why is the EU Proposing MDR Simplification Now?
Over the past few years, the implementation of the EU MDR has exposed severe structural issues. According to industry research, small and medium-sized enterprises (SMEs) face disproportionate compliance cost pressures, with a single clinical evaluation potentially costing between €30,000 and €250,000 . More critically, due to the limited capacity of Notified Bodies, certification delays typically stretch from 13 to 24 months .
This situation has not only forced some manufacturers to abandon the European market in favor of regions with more predictable regulatory pathways, such as the United States, but has also put low-margin "Orphan Devices" at risk of discontinuation, directly threatening the health and lives of European patients . It is under this immense industry pressure that the European Commission introduced this sweeping simplification proposal.
5 Core Benefits of the Late-2025 EU MDR Simplification Proposal
If this proposal (COM(2025) 1023) is successfully adopted, it will have a profound and positive impact on medical device manufacturers. Below are the five core changes most relevant to enterprises:
- CE Certificates Will Be "Valid Indefinitely"
Under current regulations, MDR CE certificates have a maximum validity of 5 years, requiring companies to undergo a cumbersome recertification process periodically. The new proposal suggests that CE certificates will no longer have a fixed expiration date (i.e., valid indefinitely), unless a Notified Body deems it necessary to limit the validity based on risk considerations . Instead, Notified Bodies will ensure continuous product compliance through regular Surveillance Audits. This change will drastically reduce the administrative and financial burden of certificate renewal for companies.
- Reduced Surveillance Audit Frequency and Allowance for Remote Audits
Currently, Notified Bodies must conduct at least one on-site surveillance audit annually. The new proposal allows the frequency of surveillance audits to be reduced to once every two years, provided there is sufficient justification and no negative data from Post-Market Surveillance (PMS) or vigilance systems . Furthermore, the proposal officially establishes the legal status of Remote Audits, which will undoubtedly significantly lower travel and time costs for manufacturers based in Asia.
- Favorable Downgrading for Software as a Medical Device (SaMD)
Under current MDR rules, many medical software products (including AI medical devices) are by default classified into higher risk categories (Class IIa or higher), mandating Notified Body review. The new proposal introduces targeted modifications to the classification rules, allowing software devices to start at Class I and be upgraded based on their intended purpose and risk . This means some low-risk software may revert to Class I, permitting manufacturers to use Self-declaration and bypass the expensive and lengthy Notified Body review process.
- More Flexible Clinical Evaluation Requirements
Acquiring sufficient clinical data has always been the most expensive and time-consuming aspect of MDR certification. The new proposal expands the scope of Article 61, allowing manufacturers, with adequate justification, to rely on more non-clinical data sources, such as in vitro testing, ex vivo testing, in silico testing, and computational modeling . Concurrently, for Class IIb and Class III devices, the proposal restores a more flexible "Equivalence" pathway, allowing manufacturers to utilize published literature and peer data without needing to sign data access contracts with other manufacturers .
- 50% Reduction in Certification Fees for SMEs
To protect the innovative vitality of the European market, the proposal explicitly states that micro, small, and medium-sized enterprises meeting EU standards (Recommendation 2003/361/EC) will receive a mandatory 50% reduction in Notified Body certification fees . Additionally, the proposal requires Notified Bodies to increase fee transparency, which will help companies plan their budgets more accurately.
| Area of Reform | Current MDR Requirements | Proposed Requirements (Dec 2025 Simplification Proposal) |
|---|
| CE Certificate Validity | Maximum 5 years | No fixed term (valid indefinitely), supplemented by periodic reviews |
| Surveillance Audit Frequency | At least once annually, must be on-site | Can be relaxed to once every two years, remote audits allowed |
| Software Device Classification | Default starts at Class IIa | Starts at Class I, upgraded based on risk |
| Clinical Evaluation Data | Strictly relies on real clinical investigation data | Allows use of non-clinical data like in silico and in vitro testing |
| SME Fees | No mandatory reduction provisions | Mandatory 50% reduction in Notified Body fees |
2026: Critical Milestones Medical Device Companies Cannot Ignore
Although the simplification proposal brings hope, it is currently still in the public consultation phase (until May 6, 2026) and is expected to be officially adopted by the summer of 2026 at the earliest . During this period, the existing MDR transition timelines remain in effect. In 2026, companies must pay close attention to the following two critical milestones:
- May 26, 2026: Deadline for Custom-Made Class III Implantable Devices
For custom-made Class III implantable devices, the existing transition grace period will end on this date. Thereafter, these products must fully comply with MDR requirements to be sold in the European market .
- May 28, 2026: Mandatory Use of the EUDAMED Database
After years of delays, several core modules of the European Database on Medical Devices (EUDAMED)—including actor registration, UDI/device registration, Notified Bodies and certificates, and market surveillance—will become mandatory starting May 28, 2026 . Manufacturers must complete data cleansing and system integration before this date, or risk their products being unable to be legally placed on the market.
How Should Companies Act in the Face of the 2026-2027 Certification Bottleneck?
While the reform proposal aims to alleviate pressure on Notified Bodies, the transition periods for a massive number of Legacy Devices are concentrated around the end of 2027 (high-risk devices) and the end of 2028 (medium/low-risk devices). Consequently, 2026 and 2027 will still be the absolute peak periods for EU MDR certification .
To avoid being squeezed out during this critical period, DQS HK strongly advises manufacturers to take the following actions:
- Secure Notified Body Schedules Immediately:
Do not wait for the simplification proposal to be officially implemented before taking action. Currently, Notified Body review cycles remain lengthy; submitting applications as early as possible is the only way to ensure uninterrupted product supply.
- Inventory Your Product Portfolio
Re-evaluate your product lines based on the new proposal's classification rules and the definition of "Well-Established Technologies." Identify products that may benefit from downgrading or simplified clinical evaluation pathways to optimize your certification strategy.
- Initiate EUDAMED Registration Preparations
With less than half a year until the mandatory use deadline in May 2026, companies should immediately commence data collection and UDI assignment tasks.
Conclusion
The late-2025 EU MDR simplification proposal marks a pragmatic shift in the EU's regulatory approach from "absolute strictness" to "risk-proportionate and innovation-encouraging." For medical device companies in Hong Kong and the Asia-Pacific region, this is undoubtedly a major positive development.
