Questions & Answers

The EU MDR (Regulation 2017/745) is the regulatory framework governing medical devices in the European Union. It replaced the Medical Devices Directive (MDD) and sets stricter requirements for clinical evidence, post-market surveillance, and traceability of medical devices. The MDR applies to all medical devices (MedDevs) placed on the EU market and requires manufacturers to demonstrate conformity through a comprehensive technical dossier and, for higher-risk devices, involvement of a Notified Body for CE marking.

The MDR (EU 2017/745) governs medical devices, while the IVDR (EU 2017/746) specifically regulates in vitro diagnostic medical devices (IVDs). While both regulations share similar principles regarding safety, performance, and post-market obligations, the IVDR has specific requirements for performance evaluation, including analytical and clinical performance studies unique to IVDs. Both require CE marking for market access in Europe.

CE marking is the mandatory conformity marking for medical devices sold in the European Economic Area (EEA). It indicates that a device meets all applicable requirements of the MDR or IVDR and has undergone the appropriate conformity assessment procedure. Without CE marking, a medical device or IVD cannot be legally placed on the European market. The process involves preparing a technical dossier, conducting clinical evaluation, and for most devices, obtaining certification from a Notified Body.

Health Technology Assessment (HTA), known in Bulgarian as Оценка на здравни технологии (ОЗТ), is a systematic evaluation of the properties, effects, and impacts of health technologies including medical devices. HTA assesses clinical effectiveness, cost-effectiveness, safety, and broader societal implications to support informed healthcare decision-making. For MedTech companies, HTA is increasingly important for market access and reimbursement decisions across EU member states.

Clinical trials (clinical investigations) for medical devices are systematic studies designed to assess the safety and performance of a device in human subjects. Under the MDR, clinical investigations must follow strict protocols compliant with ISO 14155 and require approval from national competent authorities and ethics committees. They are essential for generating the clinical evidence required for CE marking, particularly for higher-risk and novel medical devices.

A technical dossier (technical documentation) is a comprehensive collection of documentation that demonstrates a medical device meets all applicable regulatory requirements under the MDR or IVDR. It typically includes: device description and specifications, design and manufacturing information, risk management file (ISO 14971), clinical evaluation report, biocompatibility assessment, labelling and instructions for use, and post-market surveillance plan. Technical dossier preparation is a core service offered by CEHP.

Secondary manufacturing refers to processes performed on medical devices after primary production, including packaging, labelling, sterilization, kitting, and preparation for distribution. It is subject to strict regulatory requirements under the MDR/IVDR, including GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) compliance. CEHP supports manufacturers in establishing and optimizing secondary manufacturing operations while maintaining full regulatory compliance.

CEHP provides comprehensive market access support for medical device and IVD manufacturers entering or expanding within the European market. Our services include regulatory strategy development, CE marking support, HTA dossier preparation, reimbursement strategy, pricing analysis, distribution channel setup, and ongoing regulatory compliance management. We combine deep regulatory expertise with practical market knowledge to help MedTech companies successfully launch and commercialize their products across EU member states.

Post-market surveillance (PMS) is a systematic process for collecting and analyzing data about the performance and safety of a medical device once it is on the market. Under the MDR/IVDR, manufacturers are required to proactively plan and implement PMS systems, produce PMS reports and Periodic Safety Update Reports (PSURs), and conduct Post-Market Clinical Follow-up (PMCF) studies. PMS is essential for maintaining CE marking and ensuring continued patient safety.

A Notified Body is an organization designated by an EU member state to assess the conformity of medical devices before they can be placed on the market. For higher-risk medical devices (Class IIa, IIb, III) and certain IVDs, Notified Body involvement is mandatory for the conformity assessment process. The Notified Body reviews the technical documentation, conducts audits of the quality management system, and issues CE certificates. CEHP assists manufacturers throughout the entire Notified Body engagement process.