Last Updated: 28 July 2026
Obtaining medical device certification in Europe is becoming significantly more complex under current regulations. The transition from the MDD and IVDD directives to the new regulations, such as EU MDR and IVDR, made many additional requirements for medical device manufacturers. Now medical device companies are challenged to ensure the safety, effectiveness, and transparency of their products throughout their lifecycle. As your EU MDR consultant, we assist you in developing the strategy for CE marking of your medical device and help you prepare your technical documentation. Moreover, we can help you create a compelling submission package that will be approved by the competent authorities at the first attempt.
Why Partner With an Expert EU MDR Consultant? 80% Less NC
We do not offer you to prepare your technical file and leave. Morulaa Health Tech becomes a part of your project team and takes care of the documentation and Notified Body submission. Here are the reasons why you should think about working with us:
Actionable Intelligence Across NBs - We monitor the trends of questions and non-conformities raised by different notified bodies.
Proactive File Optimization – We use the actionable intelligence we gain from being active in the industry to optimize your file before submission to preemptively address the gaps Notified Bodies are looking for in the current EU MDR and EU IVDR landscape.
Specialist Writers – We have specialist writers who focus on specific sections ensuring that the reports are written with the necessary depth in areas such as risk management, clinical evaluation, and technical documentation amongst others.
Proven Track Record – Organizations that work with an experienced EU MDR consultant have a proven track record of facing 80% less non-conformities than those who tackle the Notified Body process on their own.
Morulaa Health Tech End to End Compliance for Medical Device Registration EU
Morulaa Health Tech offers medical device consulting services for both medical devices and in vitro diagnostic devices in the EU. You cannot put your medical device on the market without CE certification and marking.
Technical Documentation Preparation by Your EU MDR consultant
We prepare technical files for your medical devices to facilitate the conformity assessment process in the EU MDR Compliance and MDD framework.
EU MDR : We compile technical documentation in accordance with Annex II and III to support the declaration of conformity of your medical device with the EU MDR.
EU IVDR : Clinical Evaluation Report to support technical documentation and address the scientific validity and clinical performance of your device to ensure compliance with the EU IVDR, along with the Performance Evaluation Report.
MDD to MDR Transition for Legacy Medical Devices
Medical devices that were placed on the market under the old directive need to transition to the new regulation.
MDD to MDR Transition – We perform a gap analysis to identify what needs to be updated in your technical documentation, as well as your quality management system to bring your clinical evaluation report and post-market surveillance plan in line with the new regulation.
IVDD to IVDR Transition Guide for Legacy IVDs
IVDs that were placed on the market under the IVDD directive need to transition to the new IVDR regulation.
IVDD to IVDR Transition – We will guide you through the transition process and update your technical documentation to address the new risk-based classification system for IVDs and help it pass the heightened scrutiny of the conformity assessment process under the new regulation.
Efficient NC Remediation and EU MDR Compliance
Morulaa offers Notified Body non conformity (NC) remediation services for technical files to address technical deficiencies that may interfere with the audit process in line with EU MDR (2017/745) and IVDR (2017/746). For instance,
Establishing Traceability: Morulaa aids in establishing traceability matrices to address GSPR deficiencies. We determine whether each identified hazard enumerated in your ISO 14971 risk management file such as overcurrent and cross contamination among others has been adequately addressed by specific design controls, EN 62366-1 usability summative evaluation and associated clinical performance claims.
Biological & Material Safety (Annex II): In addition, we address biological and material safety assessment deficiencies raised in annex II including those concerning CMR substances such as Cobalt and phthalates. For example, Morulaa assists in developing documented information on identified concentrations of substances and performs toxicological risk assessment to demonstrate compliance with GSPR 10.4.1 thus establishing conformity of the Biological Evaluation Plan (BEP) with ISO 10993-1.
Clinical Evidence Remediations: Besides, we offer clinical evidence remediation services to address deficiencies raised on the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). For legacy devices or those similar to comparator devices, we address the issue of ‘equivalence’ as required by Annex XIV, Article 61(10) mapping out clinical or preclinical evidence to specific clinical and non-clinical performance claims and objectives while demonstrating benefit risk ratio based on the State of the Art (SoTA).
Finally, we address lifecycle deficiencies raised on consistency between shelf life data, accelerated ageing (ASTM F1980), and labelling. For instance, we can assist in evaluating statistical justification for sample size used in accelerated ageing or establishing whether labelling of your eIFU is consistent with Regulation 2021/2226 among other issues. We also verify consistency of other data elements within your technical file.
By providing consultancy services in EU IVDR or EU MDR we are able to remedy the documents raised during NB audit to address the queries raised by the Notified Bodies thus helping you achieve EU MDR compliance or IVDR compliance for successful CE marking of your device.
Secure Market Access via the Best EUIVDR Consultant
Avoid the challenges associated with documentation non-conformities and unexpected queries from Notified Bodies when registering your device by working with Morulaa Health Tech. As the best EU MDR consultant we offer support for MDD to MDR transition and IVDD to IVDR transition to ensure your legacy devices have a competitive advantage over other similar products.
Achieving full compliance with the EU MDR regulation necessitates engaging our expert EU MDR consultant team. We have extensive experience in addressing complex technical deficiencies and responding to NB queries raised during audits. To ensure your devices meet the requirements of the EU MDR regulation, consult our EU MDR consultant team to discuss your medical device or IVDD registration requirements or final MDD to MDR transition plan.
Frequently Asked Questions (FAQs)
How do we ensure our documentation meets the new UDI and traceability rules from day one?
UDI and traceability is one of the biggest challenges manufacturers face during MDD to MDR transition. We design the unique device identification and labelling requirements in your technical file in advance to make sure that your PMS, clinical evaluation, and vigilance reporting are structured for EUDAMED registration without additional expenses and delays.
