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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance

General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)

CE-marking process for medical devices CE-marking process for in vitro diagnostics PRRC under MDR or IVDR Checklists >>

CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

Post-market surveillance system

The Post-market surveillance system holds significant importance for medical device companies seeking to obtain the CE marking and maintain regulatory compliance. As a key component of the European Medical Device Regulation or In Vitro Diagnostic Medical Device Regulation requirements, a robust PMS system plays a crucial role in the CE marking process.

Post-market surveillance system

The Post-market surveillance system holds significant importance for medical device companies seeking to obtain the CE marking and maintain regulatory compliance. As a key component of the European Medical Device Regulation or In Vitro Diagnostic Medical Device Regulation requirements, a robust PMS system plays a crucial role in the CE marking process.

We assist in the establishment of data collection mechanisms to efficiently gather post-market data from various sources and ensure that risk management processes are integrated into the PMS system, allowing for the early identification and assessment of potential risks associated with your medical devices.

We help develop comprehensive PMS documentation, including operating procedures, data analysis protocols, and reporting templates, ensuring a systematic and organised approach to post-market data handling.

Our services include conducting a PMS gap analysis to identify areas that require improvement to align with regulatory requirements and industry best practices. Based on the analysis results, we work closely with your team to design a customised PMS system that captures relevant data, monitors device performance, and facilitates timely reporting of adverse events and safety issues.

Contact us today to explore how our services can enhance your post-market surveillance capabilities and contribute to the growth and success of your medical devices in the EU market.

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Our EU office

MedDev Compliance Ltd
Souliou 1, Strovolos, 2018 Nicosia, Cyprus
Phone: +357 22253765
Email: info@mdrc-services.com

			©2025 MDRC - Medical Devices Regulatory Compliance

			Solutions
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			Technical documentation

			Risk management

			Clinical evaluation

			Notified bodies

			Quality management system

			Post-market surveillance system

			Your products
	    Medical devices and medical equipment

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		Resources
		Medical Device Regulation (MDR) - basics

		CE-marking process for medical devices

     	CE-marking process for in vitro diagnostic medical devices

     	UDI infographic

     	EUDAMED registration step by step instruction

     	Checklists
		MDR technical documentation checklist

		IVDR technical documentation checklist

	   	Technical documentation checklist for medical device software (MDSW)

		MDR-compliant quality system documentation checklist

		Clinical Evaluation Plan checklist

		Clinical Evaluation Report checklist

All checklists >>

Useful informationCE-Certificate vs. EC-Certificate
Basic UDI-DI (bUDI) 
EUDAMED registration - a brief guide
Authorised Representative Mandate
GSPR – General Safety and Performance Requirements
How to obtain CE marking for medical software under the EU MDR or IVDR?
Technical documentation for Medical Device Software in the EU
Read more >>

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We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
 We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

PRRC under MDR or IVDR

UDI infographic

EUDAMED registration step by step instruction

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.