For medical device manufacturers aiming to access the European market, complying with evolving regulations is essential to ensure patient safety, maintain quality standards, and stay competitive.
With growing demands for transparency and patient safety, the European Union has replaced the Medical Devices Directive (MDD) with the Medical Device Regulation (MDR).
This new framework brings clearer and stricter rules on which documents must be translated, making it essential for manufacturers to understand and plan for these expanded language requirements.
This blog highlights the reasons behind the transition from MDD to MDR, key changes, transition timeline and deadlines, translation requirements, and the best practices for medical device translations.
What is MDD?
The Medical Device Directive (MDD) is a regulatory framework established by the European Union in 1993 (Council Directive 93/42/EEC) to harmonize laws relted to medical devices within Europe.
Its primary purpose was to ensure the safety, performance, and free movement of medical devices in the European market by setting essential requirements that manufacturers must meet before placing their products on the market.
What is MDR?
The Medical Device Regulation (MDR), formally known as EU Regulation 2017/745, is a comprehensive regulatory framework established by the European Union to govern the safety, performance, and market surveillance of medical devices within the EU.
On May 26, 2021, the Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to provide more stringent and transparent requirements reflecting technological advances and improved patient safety standards.
What is the reason for the transition from MDD to MDR?
The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) was driven primarily by the need to enhance patient safety, improve transparency, and address shortcomings identified under the MDD framework.
Several key reasons explain this shift:
1: Increased safety concerns
The EU faced several medical device safety issues under the MDD, which exposed gaps in the regulatory system, prompting the need for stricter and more comprehensive regulations to better protect patients.
2: Technological advancements
Since the MDD was established in the 1990s, medical technology has evolved significantly. The MDR updates the regulatory framework to reflect these advances and ensure that new types of devices and technologies are adequately regulated.
3: More rigorous requirements
The MDR introduces stronger clinical evidence requirements, enhanced post-market surveillance, and stricter oversight of notified bodies to ensure devices meet higher safety and performance standards.
4: Improved transparency and traceability
MDR mandates the implementation of a Unique Device Identification (UDI) system and the establishment of a comprehensive European database (EUDAMED), improving device traceability and market surveillance.
5: Lifecycle approach
Unlike the MDD, which focused mainly on pre-market approval, the MDR adopts a lifecycle approach to regulation, emphasizing continuous monitoring and risk management throughout the device’s entire market life.
6: Harmonization and clarity
The MDR is a regulation (not a directive), meaning it is directly applicable in all EU member states without the need for national transposition, reducing inconsistencies and improving regulatory clarity across the EU.
The transition period was extended until 2024 (and in some cases 2028) to give manufacturers, notified bodies, and authorities time to adapt to the stricter MDR requirements.
What is the Transition Timeline and Deadlines from MDD to MDR?
The transition timeline and deadlines from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) have been extended by the European Union to address challenges in certification capacity and to avoid device shortages.
The key deadlines are as follows:
- Class III custom-made implantable devices: The Transition deadline is 26 May 2026.
- All other Class III devices and Class IIb implantable devices (with some exceptions): Deadline is 31 December 2027.
- Class IIb devices (non-implantable with some exceptions), Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function: Deadline is 31 December 2028.
These deadlines apply to legacy devices that were certified under MDD and need to transition to MDR certification.
Conditions for extension eligibility:
Manufacturers must have:
- Applied for MDR certification by 26 May 2024 before the MDD certificate expired.
- Had a contract in place with an MDR notified body by 26 September 2024.
The extension allows MDD certificates to remain valid during this period under certain conditions, including no significant changes to device design or intended purpose, and the device not presenting an unacceptable health risk.
What are the Key changes made from MDD and MDR?
Key changes from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) include:
1: The new regulation is roughly four times longer than the Medical Device Directive (MDD) and includes five additional annexes.
2: Annex I introduces new requirements for legacy CE-marked devices, requiring re-certification.
3: Unique Device Identification (UDI) will be mandatory on all labels for supply chain tracking.
4: The definition of medical devices now includes non-medical and aesthetic products like dermal fillers and cosmetic devices.
5: Clinical evaluation and post-market follow-up are stricter, especially for Class III and implantable devices.
6: Post-market surveillance requires proactive monitoring and Periodic Safety Update Reports (PSUR).
7: Companies will have to update clinical data, technical files, and labeling to meet the new rules.
8: Core processes such as quality assurance, risk management, and post-market surveillance need review and updates.
9: In vitro diagnostic devices (IVDs) will be divided into four risk classes, with notified body review required for about 90% of them, a significant increase from the previous 10%.
10: New rules reclassify some devices into higher risk categories, impacting conformity assessments.
11: All incidents, injuries, and deaths must be reported in a centralized EU portal, with reporting timelines for non-serious incidents reduced from 30 to 15 days.
Also read: Fastest Growing Medical Device Markets & Need For Translation
Get your medical device translations from native linguists with medical expertise
Translation Requirements Before and After the Transition from MDD to MDR
1: Scope of Translation
MDD: Translation primarily required for Instructions for Use (IFUs), labels, and packaging. Other documents like implant cards, clinical reports, or vigilance documents were generally not mandated for translation.
MDR: Translation scope expanded significantly to include IFUs, labels, packaging, implant cards (Article 18), Summaries of Safety and Clinical Performance (SSCP), clinical investigation documentation, vigilance, and post-market surveillance (PMS) reports, certificates, and declarations.
2: Language Requirements
MDD: Language obligations were less explicit and varied by member state. Some countries accepted English for professional-use devices; others required national languages.
MDR: Article 10(11) explicitly mandates that manufacturers provide all user and patient information in the official language(s) required by each EU member state where the device is marketed. Each country specifies its language requirements (e.g., France requires French, Germany requires German).
3: Timing of Translation
MDD: Translations were often completed after CE marking, sometimes causing delays in market access.
MDR: Certain translations, especially IFUs, must be finalized and submitted before CE marking as part of the technical documentation.
4: Quality and Clarity of Translations
MDD: Less formal emphasis on translation quality, clarity, or cultural adaptation.
MDR: Strong focus on ensuring translations are clear, precise, and understandable to the intended user, including laypersons. Use of standardized symbols and illustrations is encouraged to enhance comprehension and reduce translation volume.
5: Unique Device Identifier (UDI) Requirements
MDD: No specific language requirements for UDI data.
MDR: UDI carriers and relevant data elements must be provided in the language(s) accepted by the member state where the device is marketed.
6: Post-Market Surveillance and Vigilance Documents
MDD: Limited or no explicit translation requirements for vigilance or PMS documents.
MDR: Vigilance reports, field safety notices, and PMS documents must be translated when submitted to authorities.
7: Responsibilities of Economic Operators
MDD: Less clearly defined responsibilities for importers and distributors regarding translation verification.
MDR: Importers and distributors are required to verify that manufacturers have provided correct translations before placing devices on the market.
8: Centralized Database Submissions (EUDAMED)
MDD: No centralized multilingual database requirements.
MDR: Data submitted to EUDAMED must be in English or local languages, depending on the member state’s rules.
9: Impact on Manufacturers
MDD: Translation burden was lower, with more fragmented enforcement and less regulatory scrutiny.
MDR: Translation requirements are significantly increased in volume, complexity, and cost, requiring strategic planning, continuous updates, and close collaboration with expert translators.
10: Translation of Digital Content
MDD: Limited or no explicit requirements for software or digital interfaces.
MDR: Requires translation of software user interfaces and digital instructions according to national language rules.
Best practices for medical device translations
1: Work with Certified Medical Translation Agencies and Experts
Choose medical device translation agencies that certified to ISO 17100 (translation quality), ISO 9001 (quality management), and ISO 13485 (medical device quality management) to ensure accuracy, consistency, and regulatory compliance.
These agencies work with professional medical translators and subject matter experts (SMEs) who have deep expertise in medical terminology and device-specific language. They ensure that complex medical content is translated clearly, safely, and in line with EU regulatory standards.
Also read: Top Medical Device Translation Companies
2: Ensure Regulatory Compliance
Strictly adhere to local and international regulations, including FDA (USA), EMA (Europe), and EU MDR requirements. Translations must precisely communicate warnings, instructions, and technical details to meet legal standards
3: Use a Standardized Translation Workflow
Implement a collaborative, standardized workflow using translation management systems (TMS), translation memories, and terminology databases. This approach promotes consistent, high-quality translations across all materials.
4: Implement Rigorous Quality Assurance
Establish multi-stage quality assurance processes involving native-speaker linguistic checks, technical reviews by medical experts, and regulatory audits.
5: Documentation & Record Keeping
Maintain detailed records of all translations, checklists, and related materials to accommodate regulatory updates and facilitate ongoing translation management.
6: Align Translation with ISO 13485 Requirements
ISO 13485 defines quality management standards for medical devices, including strict control over documentation.
Aligning your translation processes with ISO 13485 ensures all translated materials are consistent, well-documented, and meet high-quality standards. This helps guarantee accurate, compliant translations that support overall regulatory approval.
Conclusion
Adherence to the EU Medical Device Regulation is essential for medical device manufacturers aiming to access and remain in the European market.
MDR ensures higher standards of safety, performance, and transparency across the medical device lifecycle.
The regulation introduces stricter requirements for translating essential documentation into the official languages of each EU member state where the device is marketed or used.
By meeting these language requirements, manufacturers not only comply with regulation but also improve patient safety, build regulatory trust, and enable smoother market access across Europe.
Are You Looking for professional Medical Device Translations?
FAQS ON MDD vs MDR translation requirements
What are the main differences between the Medical Device Directive (MDD) and Medical Device Regulation (MDR) regarding language and translation?
Under MDD, language and translation requirements were less prescriptive, allowing some flexibility (often English was acceptable in many markets). MDR mandates that all documentation, labeling, instructions, and safety information be available in the official language(s) of each EU member state where the device is marketed, drastically increasing the scope and rigor of translation needs.
Which documents must be translated under the MDR, but not necessarily under the MDD?
MDR specifically requires translation of vigilance reports, field safety notices, post-market surveillance (PMS) documents, and virtually all user-facing and regulatory documentation submitted to authorities. MDD often did not explicitly require these translations.
How do the translation quality standards differ under MDR compared to MDD?
MDR sets stricter quality standards: translations must be accurate, validated, and adapted to the target user (e.g., layperson vs medical professional), ensuring patient safety and product comprehension. MDD lacked such explicit requirements for translation accuracy and user adaptation.
Are there new requirements for localizing content under MDR?
Yes, MDR goes beyond translation, requiring full localization this means adapting documents for the end user’s experience, education, and knowledge level, as well as the legal norms of each member state.
How many languages might I need to support for MDR compliance?
Depending on your target markets, you may need to translate documents into over 20 official languages of EU member states.
Does the MDR affect the costs and timelines for translation?
Yes, the broadened requirements significantly raise translation costs and extend timelines compared to MDD. However, leveraging specialized translation providers, early planning, and translation memory systems can help manage and mitigate these increases.
When did MDD change to MDR?
The MDR officially replaced the MDD on May 26, 2021, with a transition period ending widely by May 27, 2024, after which all devices must comply with MDR requirements.
