MDR Certifications in EU and what it really means for Digital Health?
We would like to start with some amazing news: Our digital health platform has now been certified as a Class IIa medical device under the EU Medical Device Regulation (MDR). 🎉🎉
This certification marks a significant milestone for us, ensuring that our digital health platform meets the highest standards of safety, performance, and compliance in the EU market, but what does being a Class IIa medical device really mean? And how does the EU MDR impact digital health products like ours?
In today’s post, we’ll break down the key aspects of EU MDR certification, what it takes to achieve compliance, and why it matters for healthcare innovation.
First things first:
What is EU MDR Certification?
In the ever-evolving world of digital health, regulatory compliance is a crucial milestone that sets apart truly reliable solutions from the rest. The world of medical devices is complex and constantly evolving and the EU MDR is a comprehensive legal framework designed to ensure that all medical devices sold in the EU meet strict safety and performance standards.
Medical devices are categorized under EU MDR (Regulation (EU) 2017/745) based on their risk level, intended use, and duration of contact with the human body. The classification system includes:
Class I – Low-risk devices (e.g., non-invasive instruments, reusable surgical instruments).
Class I (self-certified) – No involvement of a Notified Body.
Class I (sterile, measuring, or reusable surgical instrument) – Requires Notified Body involvement.
Class IIa – Medium-risk devices (e.g., infusion pumps, dental fillings).
Class IIb – Higher-risk devices (e.g., ventilators, blood bags).
Class III – High-risk devices (e.g., implantable pacemakers, heart valves, artificial organs).
Each classification dictates the level of regulatory oversight required, with higher classes undergoing more rigorous evaluation, including conformity assessment by a Notified Body before receiving CE marking approval.
How to Obtain an MDR Certificate?
The steps to be followed to obtain an MDR Certificate are as follows:
Step 1
Designate a Regulatory Compliance Officer who is knowledgeable in the Medical Device Regulation (MDR) and classify your device according to the MDR classification criteria.
Step 2
Establish a Quality Management System (QMS) that aligns with MDR requirements. Many organizations follow the EN ISO 13485:2016 + A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes standard to ensure compliance. Your QMS must incorporate clinical evaluation, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) strategies.
Step 3
Compile the CE Technical Documentation in accordance with Annex II and Annex III of the MDR.
Step 4
Appoint an Authorized Representative (EC REP) within the EU and register with EUDAMED to obtain a Single Registration Number (SRN) from the regulatory authorities.
Step 5
For devices other than Class I (self-certified), your QMS and Technical Documentation must undergo an assessment by a Notified Body, which is an independent entity authorized by European national authorities to conduct regulatory audits on medical devices. For Class I (self-certified) devices, evaluation by a Notified Body is not required.
Step 6
If your device falls outside Class I (self-certified), you will receive a CE marking certificate for the product and an ISO 13485 certification for your facility upon successful completion of the Notified Body audit.
Step 7
Draft a Declaration of Conformity (DoC) in accordance with Annex IV of the MDR. This legally binding document confirms that your device complies with all relevant European regulations. Once completed, the CE marking can be applied to your product.
So, where does our digital health platform fit into this?
We’ve achieved Class IIa certification, a designation for devices that present a moderate risk and typically support medical decision-making or assist in patient management. This means our platform has undergone rigorous evaluation to meet high standards of safety, effectiveness, and quality. For healthcare professionals and patients alike, this certification is more than just a regulatory milestone—it’s a mark of trust and reliability. But what does that really mean, both for us and for our users? Let’s break it down in an easy-to-understand way, exploring the significance of this certification, how it impacts our platform,and why it matters for patients and doctors:
Stronger Safety Measures: Our platform has passed extensive testing to ensure compliance with strict safety standards, covering data privacy and technical performance. As a Class IIa device, our platform is continuously monitored and audited to maintain performance and safety.
Improved Trust: Users can confidently engage with our platform, knowing it meets EU and international standards.
Enhanced User Experience: The certification has driven improvements in the user interface, security, and patient monitoring features.
Looking Ahead: What’s Next for Our Platform?
Achieving MDR Class IIa certification is just the beginning. We are committed to ongoing updates, user feedback integration, and expanding capabilities.
Ongoing Updates: We’ll ensure compliance with evolving regulations and technologies.
We’re incredibly proud of achieving EU MDR Class IIa certification for our digital health platform, as it’s a testament to our commitment to delivering a safe, reliable, and effective tool for improving health outcomes. It’s not just a regulatory achievement—it’s a milestone that ensures we continue to provide the highest level of care through our technology.
Want to See Actimi in Action?
If you're a healthcare provider, insurance company, or medical professional looking to implement remote patient monitoring and telemedicine, we offer personalized demos to showcase how our solutions can enhance your healthcare services.
Contact for Collaboration Opportunities
If you are interested in this topic, we would love to hear from you. Send us an email at info@actimi.com or use the appointment module on this page.
Resource:
https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
https://www.medical.saint-gobain.com/resources/blog/eu-mdr-what-it-and-why-it-necessary
MDR Certifications in EU and what it really means for Digital Health?
We would like to start with some amazing news: Our digital health platform has now been certified as a Class IIa medical device under the EU Medical Device Regulation (MDR). 🎉🎉
This certification marks a significant milestone for us, ensuring that our digital health platform meets the highest standards of safety, performance, and compliance in the EU market, but what does being a Class IIa medical device really mean? And how does the EU MDR impact digital health products like ours?
In today’s post, we’ll break down the key aspects of EU MDR certification, what it takes to achieve compliance, and why it matters for healthcare innovation.
First things first:
What is EU MDR Certification?
In the ever-evolving world of digital health, regulatory compliance is a crucial milestone that sets apart truly reliable solutions from the rest. The world of medical devices is complex and constantly evolving and the EU MDR is a comprehensive legal framework designed to ensure that all medical devices sold in the EU meet strict safety and performance standards.
Medical devices are categorized under EU MDR (Regulation (EU) 2017/745) based on their risk level, intended use, and duration of contact with the human body. The classification system includes:
Class I – Low-risk devices (e.g., non-invasive instruments, reusable surgical instruments).
Class I (self-certified) – No involvement of a Notified Body.
Class I (sterile, measuring, or reusable surgical instrument) – Requires Notified Body involvement.
Class IIa – Medium-risk devices (e.g., infusion pumps, dental fillings).
Class IIb – Higher-risk devices (e.g., ventilators, blood bags).
Class III – High-risk devices (e.g., implantable pacemakers, heart valves, artificial organs).
Each classification dictates the level of regulatory oversight required, with higher classes undergoing more rigorous evaluation, including conformity assessment by a Notified Body before receiving CE marking approval.
How to Obtain an MDR Certificate?
The steps to be followed to obtain an MDR Certificate are as follows:
Step 1
Designate a Regulatory Compliance Officer who is knowledgeable in the Medical Device Regulation (MDR) and classify your device according to the MDR classification criteria.
Step 2
Establish a Quality Management System (QMS) that aligns with MDR requirements. Many organizations follow the EN ISO 13485:2016 + A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes standard to ensure compliance. Your QMS must incorporate clinical evaluation, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) strategies.
Step 3
Compile the CE Technical Documentation in accordance with Annex II and Annex III of the MDR.
Step 4
Appoint an Authorized Representative (EC REP) within the EU and register with EUDAMED to obtain a Single Registration Number (SRN) from the regulatory authorities.
Step 5
For devices other than Class I (self-certified), your QMS and Technical Documentation must undergo an assessment by a Notified Body, which is an independent entity authorized by European national authorities to conduct regulatory audits on medical devices. For Class I (self-certified) devices, evaluation by a Notified Body is not required.
Step 6
If your device falls outside Class I (self-certified), you will receive a CE marking certificate for the product and an ISO 13485 certification for your facility upon successful completion of the Notified Body audit.
Step 7
Draft a Declaration of Conformity (DoC) in accordance with Annex IV of the MDR. This legally binding document confirms that your device complies with all relevant European regulations. Once completed, the CE marking can be applied to your product.
So, where does our digital health platform fit into this?
We’ve achieved Class IIa certification, a designation for devices that present a moderate risk and typically support medical decision-making or assist in patient management. This means our platform has undergone rigorous evaluation to meet high standards of safety, effectiveness, and quality. For healthcare professionals and patients alike, this certification is more than just a regulatory milestone—it’s a mark of trust and reliability. But what does that really mean, both for us and for our users? Let’s break it down in an easy-to-understand way, exploring the significance of this certification, how it impacts our platform,and why it matters for patients and doctors:
Stronger Safety Measures: Our platform has passed extensive testing to ensure compliance with strict safety standards, covering data privacy and technical performance. As a Class IIa device, our platform is continuously monitored and audited to maintain performance and safety.
Improved Trust: Users can confidently engage with our platform, knowing it meets EU and international standards.
Enhanced User Experience: The certification has driven improvements in the user interface, security, and patient monitoring features.
Looking Ahead: What’s Next for Our Platform?
Achieving MDR Class IIa certification is just the beginning. We are committed to ongoing updates, user feedback integration, and expanding capabilities.
Ongoing Updates: We’ll ensure compliance with evolving regulations and technologies.
We’re incredibly proud of achieving EU MDR Class IIa certification for our digital health platform, as it’s a testament to our commitment to delivering a safe, reliable, and effective tool for improving health outcomes. It’s not just a regulatory achievement—it’s a milestone that ensures we continue to provide the highest level of care through our technology.
Want to See Actimi in Action?
If you're a healthcare provider, insurance company, or medical professional looking to implement remote patient monitoring and telemedicine, we offer personalized demos to showcase how our solutions can enhance your healthcare services.
Contact for Collaboration Opportunities
If you are interested in this topic, we would love to hear from you. Send us an email at info@actimi.com or use the appointment module on this page.
Resource:
https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
https://www.medical.saint-gobain.com/resources/blog/eu-mdr-what-it-and-why-it-necessary
MDR Certifications in EU and what it really means for Digital Health?
We would like to start with some amazing news: Our digital health platform has now been certified as a Class IIa medical device under the EU Medical Device Regulation (MDR). 🎉🎉
This certification marks a significant milestone for us, ensuring that our digital health platform meets the highest standards of safety, performance, and compliance in the EU market, but what does being a Class IIa medical device really mean? And how does the EU MDR impact digital health products like ours?
In today’s post, we’ll break down the key aspects of EU MDR certification, what it takes to achieve compliance, and why it matters for healthcare innovation.
First things first:
What is EU MDR Certification?
In the ever-evolving world of digital health, regulatory compliance is a crucial milestone that sets apart truly reliable solutions from the rest. The world of medical devices is complex and constantly evolving and the EU MDR is a comprehensive legal framework designed to ensure that all medical devices sold in the EU meet strict safety and performance standards.
Medical devices are categorized under EU MDR (Regulation (EU) 2017/745) based on their risk level, intended use, and duration of contact with the human body. The classification system includes:
Class I – Low-risk devices (e.g., non-invasive instruments, reusable surgical instruments).
Class I (self-certified) – No involvement of a Notified Body.
Class I (sterile, measuring, or reusable surgical instrument) – Requires Notified Body involvement.
Class IIa – Medium-risk devices (e.g., infusion pumps, dental fillings).
Class IIb – Higher-risk devices (e.g., ventilators, blood bags).
Class III – High-risk devices (e.g., implantable pacemakers, heart valves, artificial organs).
Each classification dictates the level of regulatory oversight required, with higher classes undergoing more rigorous evaluation, including conformity assessment by a Notified Body before receiving CE marking approval.
How to Obtain an MDR Certificate?
The steps to be followed to obtain an MDR Certificate are as follows:
Step 1
Designate a Regulatory Compliance Officer who is knowledgeable in the Medical Device Regulation (MDR) and classify your device according to the MDR classification criteria.
Step 2
Establish a Quality Management System (QMS) that aligns with MDR requirements. Many organizations follow the EN ISO 13485:2016 + A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes standard to ensure compliance. Your QMS must incorporate clinical evaluation, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) strategies.
Step 3
Compile the CE Technical Documentation in accordance with Annex II and Annex III of the MDR.
Step 4
Appoint an Authorized Representative (EC REP) within the EU and register with EUDAMED to obtain a Single Registration Number (SRN) from the regulatory authorities.
Step 5
For devices other than Class I (self-certified), your QMS and Technical Documentation must undergo an assessment by a Notified Body, which is an independent entity authorized by European national authorities to conduct regulatory audits on medical devices. For Class I (self-certified) devices, evaluation by a Notified Body is not required.
Step 6
If your device falls outside Class I (self-certified), you will receive a CE marking certificate for the product and an ISO 13485 certification for your facility upon successful completion of the Notified Body audit.
Step 7
Draft a Declaration of Conformity (DoC) in accordance with Annex IV of the MDR. This legally binding document confirms that your device complies with all relevant European regulations. Once completed, the CE marking can be applied to your product.
So, where does our digital health platform fit into this?
We’ve achieved Class IIa certification, a designation for devices that present a moderate risk and typically support medical decision-making or assist in patient management. This means our platform has undergone rigorous evaluation to meet high standards of safety, effectiveness, and quality. For healthcare professionals and patients alike, this certification is more than just a regulatory milestone—it’s a mark of trust and reliability. But what does that really mean, both for us and for our users? Let’s break it down in an easy-to-understand way, exploring the significance of this certification, how it impacts our platform,and why it matters for patients and doctors:
Stronger Safety Measures: Our platform has passed extensive testing to ensure compliance with strict safety standards, covering data privacy and technical performance. As a Class IIa device, our platform is continuously monitored and audited to maintain performance and safety.
Improved Trust: Users can confidently engage with our platform, knowing it meets EU and international standards.
Enhanced User Experience: The certification has driven improvements in the user interface, security, and patient monitoring features.
Looking Ahead: What’s Next for Our Platform?
Achieving MDR Class IIa certification is just the beginning. We are committed to ongoing updates, user feedback integration, and expanding capabilities.
Ongoing Updates: We’ll ensure compliance with evolving regulations and technologies.
We’re incredibly proud of achieving EU MDR Class IIa certification for our digital health platform, as it’s a testament to our commitment to delivering a safe, reliable, and effective tool for improving health outcomes. It’s not just a regulatory achievement—it’s a milestone that ensures we continue to provide the highest level of care through our technology.
Want to See Actimi in Action?
If you're a healthcare provider, insurance company, or medical professional looking to implement remote patient monitoring and telemedicine, we offer personalized demos to showcase how our solutions can enhance your healthcare services.
Contact for Collaboration Opportunities
If you are interested in this topic, we would love to hear from you. Send us an email at info@actimi.com or use the appointment module on this page.
Resource:
https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
https://www.medical.saint-gobain.com/resources/blog/eu-mdr-what-it-and-why-it-necessary
Updated date:
Apr 25, 2025
