Danem Test & Certificate supports medical device manufacturers with MDR readiness and certification preparation for the European Union market. MDR projects require structured planning across technical documentation, quality management, clinical evidence, risk management, and post-market obligations.
We support clients from early scope definition through documentation gap assessment, planning of evidence packages, and guidance across key MDR deliverables. Our approach is tailored to device type, classification, intended purpose, and the maturity of existing documentation, helping manufacturers reduce rework and avoid delays caused by incomplete evidence.
From the outset, we define a clear scope, priorities, and expected timelines to support a structured and transparent path toward MDR readiness and certification activities.
What Is the EU Medical Device Regulation (MDR)?
The Medical Device Regulation (EU) 2017/745 is the EU legal framework governing medical devices placed on the European market. MDR strengthens requirements related to clinical evidence, risk management, technical documentation, post-market surveillance, and traceability compared to previous directives.
The applicable certification route depends on device classification, intended purpose, and whether Notified Body involvement is required. MDR preparation typically includes structured documentation, quality management alignment, and evidence planning to support conformity assessment.
Typical device categories include diagnostic and monitoring devices, therapeutic devices, medical software, implantable and non-implantable devices, and accessories intended for clinical or consumer healthcare use.
MDR Certification Support Process
Our PPE process is structured to keep requirements clear and reduce costly iterations.
Scope and classification review
We review device intended purpose and classification drivers to confirm the applicable MDR route and key requirements.
Evidence planning and remediation support
We support planning of evidence packages and corrective actions to close identified gaps and align documentation with MDR expectations.
Documentation and gap assessment
We assess technical documentation readiness and identify gaps across risk management, clinical evidence, labeling, and required MDR deliverables.
Conformity assessment readiness
We support final readiness of MDR documentation for conformity assessment activities and preparation for interactions with the relevant assessment bodies.
Preparing forr MDR Conformity Assessment?
Define classification, close documentation gaps, and structure clinical and risk evidence before engaging with your Notified Body.
Does MDR apply to my product, and how is device classification determined?
MDR applies to medical devices and certain accessories and software placed on the EU market. Classification depends on intended purpose, risk profile, and applicable MDR rules, which we confirm during the initial review.
Is a Notified Body always required under MDR?
Not always. Notified Body involvement depends on device class and applicable route. We help confirm whether Notified Body assessment is required for your device.
What are the most common gaps found during MDR readiness reviews?
Frequent gaps include incomplete clinical evidence planning, weak traceability between claims and evidence, missing post-market surveillance planning, and outdated risk management documentation. Early gap assessment reduces rework.
Can existing MDD documentation be reused for MDR?
Often yes, but it typically requires updates and restructuring to match MDR expectations. We help map existing documentation to MDR requirements and identify what needs to be added or improved.
How long does MDR preparation typically take?
Timelines depend on device class, documentation maturity, clinical evidence needs, and organizational readiness. A structured plan and early gap assessment help make timelines predictable.