What This Page Covers
We support medical device manufacturers across the full product lifecycle: regulatory strategy, QMS, design & development, technical documentation, clinical evaluation, Notified Body interactions, and post-market obligations, covering EU MDR, UKCA, and global market access (via regulanet®).
This page covers medical devices regulated under EU MDR 2017/745: non-active devices (surgical instruments, implants, wound care, dental devices), active devices (electromechanical, powered, energy-delivering), and substance-based devices. For software as a medical device (SaMD), standalone medical device software (MDSW), and AI-enabled devices, see Digital Health & SaMD. For in vitro diagnostics, see In Vitro & Companion Diagnostics. For drug-device combination products, see Combination Products.
Visitors who previously worked with CE plus will find the same teams and expertise here. CE plus has been fully integrated into regenold, and all device, IVD, and software capabilities continue under the regenold brand.
What Changed with MDR
Manufacturers who were certified under the Medical Device Directive sometimes underestimate how much has changed. MDR is not an update to the MDD; it is a different regulatory system with different evidence standards and different obligations. A few things that catch manufacturers off guard:
Classification can change.
MDR introduced new classification rules (e.g., Rule 11 for software, Rule 21 for substance-based devices) and reclassified some device types upward. Devices that were Class I under MDD may now be Class IIa or higher. Classification should be reassessed from scratch against MDR Annex VIII rather than assumed.
Clinical evidence requirements are substantially higher.
MDR requires a clinical evaluation based on sufficient clinical data, and “sufficient” means more than it did under MDD. For Class III and implantable devices, clinical investigations are generally expected unless equivalence to an existing device can be demonstrated, and MDR’s equivalence requirements (technical, biological, and clinical equivalence, with full access to the equivalent device’s data) are much stricter than MDD’s. For lower-risk devices, clinical evaluation through literature and post-market clinical follow-up data may be acceptable in certain cases, but the depth and quality of the evaluation report must meet the standards set out in MEDDEV 2.7/1 Rev 4 and the growing body of MDCG guidance.
Post-market surveillance is no longer a formality.
MDR mandates PMS Plans, PMS Reports (for Class I) or Periodic Safety Update Reports (for Class IIa and above), and Post-Market Clinical Follow-up (PMCF) plans and reports. For higher-risk devices, PSURs must be submitted annually to the Notified Body. This is ongoing work, not a one-time deliverable.
EUDAMED is becoming mandatory.
As of November 2025, four core EUDAMED modules are fully functional, triggering a six-month transition. From May 2026, manufacturers, authorised representatives, importers, and Notified Bodies must comply with registration, UDI, and certificate notification obligations. Vigilance reporting through EUDAMED is expected to follow.
Further reform is already on the table.
The European Commission proposed amendments to MDR and IVDR in December 2025, covering Notified Body pricing transparency and standardised timelines, “well-established technology” simplified requirements, breakthrough and orphan device designations, and risk-based recertification. These are not yet in force and will be amended during the legislative process, but they signal the direction of reform.
The Practical Reality: Transition Deadlines and Notified Body Capacity
The transition from MDD/AIMDD to MDR operates on staggered deadlines:
- Class III and implantable Class IIb devices: MDR certification required by 31 December 2027.
- Class IIa, non-implantable Class IIb, and Class I (sterile/measuring): MDR certification required by 31 December 2028.
- Class III custom-made implantable devices: MDR compliance required by 26 May 2026.
The bottleneck is Notified Body capacity. Conformity assessments under MDR are taking 6 to 18 months on average, and longer for complex devices. Manufacturers who have not yet submitted their applications are at serious risk of gaps in certification. We work with manufacturers on submission timing, Notified Body selection, and pre-submission preparation to reduce the risk of delays.
QMS Under MDR
MDR requires a quality management system (ISO 13485 is the recognised standard) that covers the full device lifecycle: design and development, supplier controls, production, post-market surveillance, vigilance, and corrective actions. The QMS is audited by the Notified Body as part of the conformity assessment, and surveillance audits continue throughout the certificate’s validity.
A few points that matter in practice: the QMS must include a process for evaluating whether changes to the device constitute “significant changes” under MDR (triggering supplementary audit). Risk management (ISO 14971) must be integrated across the QMS, not treated as a standalone activity. And the Person Responsible for Regulatory Compliance (PRRC) must have documented qualifications and be available within the organisation (or, for SMEs, externally available). The December 2025 Commission simplification proposal would relax some PRRC requirements for SMEs, but this is not yet adopted.
Applicable Services Across the Development Journey
Discovery & Concept
Device classification under MDR Annex VIII (and reassessment if transitioning from MDD). Intended purpose definition. Regulatory pathway mapping: conformity assessment route, Notified Body involvement (self-declaration for most Class I; Notified Body assessment for Class IIa, IIb, III). Identification of applicable standards (ISO 13485, ISO 14971, IEC 62304 for software components, IEC 60601 series for active devices). Initial market strategy: EU, UK (UKCA), US (510(k)/De Novo/PMA), and other target markets.
Preclinical
Biocompatibility evaluation (ISO 10993 series). Sterilisation validation where applicable (ISO 11135, ISO 11137, ISO 17665). Electrical safety and EMC testing for active devices (IEC 60601). Shelf life and packaging validation (ISO 11607). Usability engineering (IEC 62366). Risk management file initiation under ISO 14971.
Design & Development
Technical documentation compilation per MDR Annex II (device description, design and manufacturing information, GSPR checklist, benefit-risk analysis, product verification and validation). Clinical evaluation plan. QMS implementation or gap assessment against ISO 13485 and MDR requirements. If software is a component: IEC 62304 software lifecycle documentation. Design transfer and design history file. UDI assignment and EUDAMED registration planning.
Clinical
Clinical evaluation report (CER) based on clinical data: literature review, clinical investigation data, and/or equivalence argumentation. Under MDR clinical investigations are often expected. PMCF plan. Notified Body pre-submission discussions on clinical strategy where beneficial.
Regulatory Submission & Approval
Conformity assessment application to the Notified Body. Technical documentation submission including CER, risk management file, and GSPR mapping. QMS audit preparation. Declaration of Conformity and CE marking upon successful assessment. For UK: UKCA route and MHRA registration. For US: 510(k), De Novo, or PMA submission in parallel if applicable. For other markets: registration strategy coordinated through regulanet®.
Launch & Market Access
EUDAMED registration (mandatory from May 2026). UDI implementation on labelling and packaging. Instructions for use and labelling compliance per MDR Annex I. Appointment of authorised representative for non-EU manufacturers. Economic operator obligations (importer, distributor).
Post-Market & Lifecycle Management
PMS Plan, PMS Report (Class I) or PSUR (Class IIa and above). PMCF studies where defined in the PMCF plan. Vigilance reporting: serious incidents within 15 days (or shorter for life-threatening events). Trend reporting. Change managements: assessment against MDCG “significant change” criteria, with Notified Body notification or new assessment where required. Certificate renewal and surveillance audits.
Example Projects
Class III Implantable Device: MDR Transition From MDD
A manufacturer of an implantable orthopaedic device needed to transition from an MDD certificate to MDR before the 2027 deadline. We conducted a gap assessment against MDR Annex II, rewrote the clinical evaluation report with updated literature search and PMCF plan, prepared the GSPR mapping, and managed the Notified Body submission and audit. MDR certificate issued within 14 months.
Class IIa Active Device: New CE Marking Under MDR
A start-up developing an active therapeutic device needed a full MDR conformity assessment with no MDD legacy. We supported classification, QMS implementation against ISO 13485, technical documentation compilation, biocompatibility and electrical safety testing strategy, clinical evaluation, and Notified Body engagement. CE marked on the first assessment cycle.
Multi-Market Registration: EU, UK, and US in Parallel
A mid-sized manufacturer launching a Class IIb substance-based device needed simultaneous EU MDR CE marking, UK registration, and marketing authorization in KSA (and other MENA countries). We coordinated the three regulatory tracks in parallel, aligning the technical documentation where possible while meeting the jurisdiction-specific requirements of each. All three milestones achieved within an 18-month window.
Developing or Placing a Medical Device on the EU Market?
Tell us about your device, its classification, and your target markets. We will assess the regulatory pathway and outline how we can support.
Speak with an ExpertFrequently Asked Questions (FAQ)
How long does an MDR conformity assessment take?
Notified Bodies are currently reporting 6 to 18 months for a standard MDR certification, and longer for complex or Class III devices. The timeline depends on the quality of the submission, the Notified Body’s workload, and the number of questions or deficiencies raised during review. Pre-submission preparation and a clean, complete technical documentation package make a significant difference.
What counts as “sufficient clinical evidence” under MDR?
It depends on the device class and risk profile. Clinical investigations are often expected. Equivalence-based argumentation is possible but MDR requires technical, biological, and clinical equivalence plus access to the equivalent device’s data, which is rarely available for competitor devices. For lower-risk devices, a well-conducted literature review, clinical experience data, and a PMCF plan may be sufficient. The clinical evaluation should be proportionate to the risk, but the bar is considerably higher than under MDD.
Is the EUDAMED registration mandatory now?
The four core modules were declared fully functional in November 2025. Mandatory use starts from May 2026 for actor registration, UDI/device registration, and certificate data. Manufacturers placing devices on the EU market should be preparing their EUDAMED registrations now.
What happens if we miss the MDR transition deadline?
Devices without a valid MDR certificate cannot be placed on the EU market after the applicable deadline. There is no sell-off deadline (this was removed by Regulation 2023/607), so devices already in the supply chain can continue to be made available. But new placements stop. For manufacturers still in the process, the priority is ensuring the MDR conformity assessment is completed before the deadline.
What is the December 2025 simplification proposal?
The Commission proposed amendments to MDR and IVDR covering Notified Body timelines and pricing, well-established technology simplifications, breakthrough and orphan device designations, broader clinical evidence definitions, and risk-based recertification. It is with Parliament and Council and will change during the legislative process. Not yet law, but worth tracking.
Do we need separate certification for the UK market?
Yes, post-Brexit. The UK operates its own regulatory system under the UK MDR (SI 2002/618 as amended). UKCA marking is required for the GB market (England, Scotland, Wales), though the UK Government has extended recognition of CE-marked devices. Northern Ireland continues to follow EU MDR under the Windsor Framework. We support parallel EU and UK submissions to avoid duplication of effort.