CE-Certificate vs. EC-Certificate
To market a medical device or IVD in the EU, a special certificate is required. But does a medical device manufacturer need a CE Certificate for sales in the European Union, or should it be an EC Certificate? This article will help you understand.
Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it
Basic UDI-DI is the identifier of a medical device within the territory of the European Union. Its presence is one of the mandatory requirements of European legislation in the field of medical devices. It emerged after the implementation of European regulations MDR 2017/745 and IVDR 2017/746.
EUDAMED registration - a brief guide
Every economic operator participating in the medical device industry in the European Union must register in EUDAMED. Registration in EUDAMED is a mandatory requirement outlined in both EU regulations governing the medical device market.
Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)
One of the important requirements of European regulations is that there must be a written agreement between the manufacturer and the Authorised Representative, officially referred to as the Authorised Representative Mandate, which European supervisory authorities may request if necessary.
Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)
One of the important requirements of European regulations is that there must be a written agreement between the manufacturer and the Authorised Representative, officially referred to as the Authorised Representative Mandate, which European supervisory authorities may request if necessary.
GSPR – General Safety and Performance Requirements for medical devices in the European Union
GSPRs form the cornerstone of medical device regulations in the EU, setting forth the essential criteria that devices must meet to ensure their safety and performance. Adherence to these requirements is crucial for both regulatory compliance and, most importantly, safeguarding the health and well-being of patients.
GSPR – General Safety and Performance Requirements for medical devices in the European Union
GSPRs form the cornerstone of medical device regulations in the EU, setting forth the essential criteria that devices must meet to ensure their safety and performance. Adherence to these requirements is crucial for both regulatory compliance and, most importantly, safeguarding the health and well-being of patients.
How to obtain CE marking for medical software under the EU MDR or IVDR?
The essential compliance criteria are similar to those for any other medical device under the EU MDR or any in-vitro diagnostic device under the IVDR. This includes adherence to the European Union's Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) for devices marketed in the EU.
Technical documentation for Medical Device Software in the EU
Technical documentation for medical device software in the EU ensures compliance with MDR and IVDR regulations. It includes essential details such as device specifications, risk management, clinical evaluation, and performance validation to support regulatory approval and safe market entry.
Technical documentation for Medical Device Software in the EU
Technical documentation for medical device software in the EU ensures compliance with MDR and IVDR regulations. It includes essential details such as device specifications, risk management, clinical evaluation, and performance validation to support regulatory approval and safe market entry.
IEC 62304 - the pivotal standard for software medical devices
Adhering to IEC 62304 is critical for medical device software developers to ensure that their products meet safety and performance standards and pass all regulatory procedures in the European Union to ensure the market entry.
Medical Device Regulation (MDR) - basics
Compliance with the MDR is essential for manufacturers looking to market their devices in the EU. MDR is of paramount importance in the field of medical devices in the EU as it significantly elevates the standards for patient safety and product quality.
ISO and IEC standards for medical device software
These standards provide a structured framework for manufacturers to ensure that their software meets the standards of reliability, safety, and performance. The standards are important for medical device companies seeking CE-marking and market access in the European Union.
Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle
The importance of clinical evaluation extends far beyond the initial stages of device development and CE certification. It forms an inseparable link with PMCF and PMS, collectively shaping a holistic approach to ensuring the ongoing safety and effectiveness of medical devices.
Notified Bodies and their role in certification of medical devices
Notified Bodies (NBs) are private organizations designated by EU member states to assess the conformity of medical devices before they are placed on the market. They play a crucial role in the European regulatory system for medical devices.
What is NANDO and why medical device companies should know about it?
NANDO is a valuable tool within the EU's regulatory infrastructure, providing transparency, accessibility, and verification capabilities for stakeholders involved in conformity assessments, particularly those related to New Approach directives and regulations.
Labeling and UDI requirements for medical devices in the EU
The label of a medical device must include essential information such as the device's intended purpose, instructions for use, contraindications, manufacturer's details, and any precautions or warnings. The information should be clear, understandable, and in...
Understanding the roles of Authorized Representatives and Importers under MDR/IVDR
Two important actors in this regulatory landscape are Authorized Representatives (ARs) and Importers, each playing distinct yet crucial roles in ensuring compliance and safety. Authorized Representatives act as a bridge between non-EU manufacturers and EU regulatory authorities.
Understanding the roles of Authorized Representatives and Importers under MDR/IVDR
Two important actors in this regulatory landscape are Authorized Representatives (ARs) and Importers, each playing distinct yet crucial roles in ensuring compliance and safety. Authorized Representatives act as a bridge between non-EU manufacturers and EU regulatory authorities.
MDR implementation - challenges and solutions
In this article, we explore these challenges to understand the nuances that demand strategic attention and present practical solutions to address these challenges and empower manufacturers in meeting regulatory demands in the EU.
MDR implementation - challenges and solutions
In this article, we explore these challenges to understand the nuances that demand strategic attention and present practical solutions to address these challenges and empower manufacturers in meeting regulatory demands in the EU.
Post-market surveillance under MDR and IVDR - requirements and best practices
The MDR and IVDR have significantly elevated the expectations and obligations surrounding post-market activities. Beyond mere compliance, these regulations underscore the importance of proactively ensuring the safety, performance, and effectiveness of medical devices in real-world scenarios.
Notified Body audit - a manufacturer's guide
A Notified Body audit for a medical device may seem like a challenging task, requiring one big effort to succeed. However, there's no one big secret trick to ace it. Success is not one big leap but a series of small, consistent steps that, when taken together, pave the way for a successful certification.
Notified Body audit - a manufacturer's guide
A Notified Body audit for a medical device may seem like a challenging task, requiring one big effort to succeed. However, there's no one big secret trick to ace it. Success is not one big leap but a series of small, consistent steps that, when taken together, pave the way for a successful certification.
Risk management plan - guide for medical device companies
MDR and IVDR state in no uncertain terms that risk management activities should be planned. Therefore, for every single medical device, the manufacturer should establish and document a Risk management plan in accordance with the manufacturer's risk management process.
Should my medical device comply with GDPR?
Generally, compliance with GDPR is necessary whenever personal data is involved in the operation, use, or processing of medical devices or IVDs to ensure the protection of individuals' privacy rights and data security. So the simple rule to determine whether or not your device must be GDPR-compliant is:
EC-certificate for a medical device - Q&A
Notified Bodies issue certificates following audits and inspections, ensuring that devices meet the safety and quality standards outlined in the two EU medical device regulations - MDR and IVDR. Only certain classes of medical devices undergo these audits and inspections and subsequently receive certification.
How long does it take to CE-mark a medical device?
Despite the complexity and variability inherent in the CE marking process for a medical device, we can attempt to outline average timelines based on industry experiences. By breaking down the process into its constituent parts and considering potential bottlenecks or delays, we aim to...
What is a PRRC?
Medical device and IVD companies operating in the EU are mandated to have a PRRC within their organization. Small and micro manufacturers may not necessarily have a PRRC within their organization but must ensure the availability of such an individual permanently and continuously.
Essential requirements for importers and distributors under MDR and IVDR
In the European Union, the roles of importers and distributors in the medical device supply chain are distinct, yet both are important in ensuring that medical devices meet regulatory requirements before reaching end-users.
Language requirements for IFUs and labels under the MDR and IVDR
The language requirements outlined in the MDR and IVDR are, at their core, clear and straightforward. Simply put, all information provided with a medical device...
Legal Manufacturer and Original Equipment Manufacturer in medical devices
In the context of medical devices, Legal Manufacturer-Original Equipment Manufacturer (LM-OEM) scheme has become a widely adopted model. It allows medical device companies to...
How to structure a PRRC contract for effective compliance
When drafting a contract for a PRRC, it’s important to clearly outline their qualifications. These qualifications should, at a minimum, meet the baseline requirements specified in Article 15.
How to Create a Declaration of Conformity According to MDR or IVDR
The Declaration of Conformity is a legally binding document that certifies your device meets EU safety, quality, and performance standards. Here’s a basic template for a DoC:
Is your software a medical device or an accessory? Understanding EU MDR classification
Is your software a medical device or an accessory under EU MDR? Discover the criteria for classification of medical device software, including intended purpose, standalone software, and risk-based classification under EU regulations.
Is your software a medical device or an accessory? Understanding EU MDR classification
Is your software a medical device or an accessory under EU MDR? Discover the criteria for classification of medical device software, including intended purpose, standalone software, and risk-based classification under EU regulations.
Clinical vs. Performance Evaluation - which one do I need?
Clinical evaluation focuses on ensuring the safety and effectiveness of medical devices under the EU MDR, while performance evaluation ensures in vitro diagnostic devices (IVDs) meet analytical and clinical performance requirements under the IVDR.
Clinical vs. Performance Evaluation - which one do I need?
Clinical evaluation focuses on ensuring the safety and effectiveness of medical devices under the EU MDR, while performance evaluation ensures in vitro diagnostic devices (IVDs) meet analytical and clinical performance requirements under the IVDR.
Understanding Systems and Procedure Packs
Systems and Procedure Packs (SPPs) combine medical devices for a specific purpose, streamlining healthcare procedures. Regulated under the EU MDR, SPPs must meet strict safety and performance standards. Learn about their definitions, regulatory requirements, compatibility challenges, and supply chain management to ensure compliance and patient safety.
Understanding Systems and Procedure Packs
Systems and Procedure Packs (SPPs) combine medical devices for a specific purpose, streamlining healthcare procedures. Regulated under the EU MDR, SPPs must meet strict safety and performance standards. Learn about their definitions, regulatory requirements, compatibility challenges, and supply chain management to ensure compliance and patient safety.
How often should Clinical Evaluation Report (CER) be updated?
The MDR emphasizes keeping evaluations current, but doesn’t specify a fixed timeline. Guidance from MEDDEV 2.7/1 recommends updates annually for high-risk devices or every 2–5 years for established low-risk devices. However, with robust Post-Market Clinical Follow-up (PMCF), CER updates may be unnecessary unless significant changes occur.
How often should Clinical Evaluation Report (CER) be updated?
The MDR emphasizes keeping evaluations current, but doesn’t specify a fixed timeline. Guidance from MEDDEV 2.7/1 recommends updates annually for high-risk devices or every 2–5 years for established low-risk devices. However, with robust Post-Market Clinical Follow-up (PMCF), CER updates may be unnecessary unless significant changes occur.
Do Manufacturers of Medical Device Parts and Unfinished Medical Device Products Need CE Marking?
Discover the key responsibilities for manufacturers of medical device parts and components under the MDR or IVDR. Learn when CE marking is required, how to ensure compliance, and the obligations for maintaining safety and performance. Understand how the MDR differentiates between replacement parts and components that alter a device's intended purpose or safety.
Do Manufacturers of Medical Device Parts and Unfinished Medical Device Products Need CE Marking?
Discover the key responsibilities for manufacturers of medical device parts and components under the MDR or IVDR. Learn when CE marking is required, how to ensure compliance, and the obligations for maintaining safety and performance. Understand how the MDR differentiates between replacement parts and components that alter a device's intended purpose or safety.
What is an EC Certificate?
An EC Certificate, issued by a Notified Body, confirms that a medical device complies with EU regulations, including MDR 2017/745 or IVDR 2017/746. It enables manufacturers to affix the CE marking and legally market their devices in the EU. Learn about its purpose, types, devices requiring it, and validity in this comprehensive guide.
What is an EC Certificate?
An EC Certificate, issued by a Notified Body, confirms that a medical device complies with EU regulations, including MDR 2017/745 or IVDR 2017/746. It enables manufacturers to affix the CE marking and legally market their devices in the EU. Learn about its purpose, types, devices requiring it, and validity in this comprehensive guide.
Does compliance with ISO 13485 automatically mean MDR compliance?
ISO 13485 compliance establishes a strong foundation for quality management in medical device manufacturing. However, it doesn't automatically fulfill all MDR requirements. While ISO 13485 aligns with certain MDR aspects, such as quality management systems, MDR demands additional compliance with clinical evaluation, post-market surveillance, UDI, and EUDAMED registration. Learn how ISO 13485 supports but doesn't replace full MDR compliance.
Does compliance with ISO 13485 automatically mean MDR compliance?
ISO 13485 compliance establishes a strong foundation for quality management in medical device manufacturing. However, it doesn't automatically fulfill all MDR requirements. While ISO 13485 aligns with certain MDR aspects, such as quality management systems, MDR demands additional compliance with clinical evaluation, post-market surveillance, UDI, and EUDAMED registration. Learn how ISO 13485 supports but doesn't replace full MDR compliance.
How to Use NANDO to Find a Notified Body for Medical Devices
Learn how to use the NANDO database to find a suitable Notified Body for your medical devices under MDR (EU 2017/745) or IVDR (EU 2017/746). This step-by-step guide explains how to search by country, legislation, or product type, and how to review the scope of notifications to ensure compatibility with your products. Streamline your path to regulatory compliance with clear and practical instructions.
How to Use NANDO to Find a Notified Body for Medical Devices
Learn how to use the NANDO database to find a suitable Notified Body for your medical devices under MDR (EU 2017/745) or IVDR (EU 2017/746). This step-by-step guide explains how to search by country, legislation, or product type, and how to review the scope of notifications to ensure compatibility with your products. Streamline your path to regulatory compliance with clear and practical instructions.
UDI-DI, Basic UDI-DI, GTIN, and GMN: What’s the Difference?
Explore the relationships between UDI-DI, Basic UDI-DI, GTIN, and GMN. Learn how UDI-DI (aligned with GS1 GTIN) uniquely identifies product variations, while Basic UDI-DI (aligned with GS1 GMN) represents device families. Ensure regulatory compliance and streamline product traceability for medical devices under MDR and IVDR.
UDI-DI, Basic UDI-DI, GTIN, and GMN: What’s the Difference?
Explore the relationships between UDI-DI, Basic UDI-DI, GTIN, and GMN. Learn how UDI-DI (aligned with GS1 GTIN) uniquely identifies product variations, while Basic UDI-DI (aligned with GS1 GMN) represents device families. Ensure regulatory compliance and streamline product traceability for medical devices under MDR and IVDR.
Legacy Device Timelines and Deadlines Under IVDR Amendments
Discover the updated timelines for legacy devices under the amended IVDR (Regulation EU 2017/746). Certificates valid as of May 2022 are extended until December 2027, with additional transitional periods for Class D, C, B, and A sterile devices. Learn the key deadlines, conditions for compliance, EUDAMED registration requirements, and notified body responsibilities to ensure seamless market access for in vitro diagnostic devices.
Legacy Device Timelines and Deadlines Under IVDR Amendments
Discover the updated timelines for legacy devices under the amended IVDR (Regulation EU 2017/746). Certificates valid as of May 2022 are extended until December 2027, with additional transitional periods for Class D, C, B, and A sterile devices. Learn the key deadlines, conditions for compliance, EUDAMED registration requirements, and notified body responsibilities to ensure seamless market access for in vitro diagnostic devices.
How the EU Artificial Intelligence Act Influences Medical Devices in the EU
The EU AI Act introduces specific obligations for AI systems in medical devices, focusing on risk management, transparency, and data governance. Learn how manufacturers must adapt to ensure compliance and maintain CE marking under MDR and IVDR.
How the EU Artificial Intelligence Act Influences Medical Devices in the EU
The EU AI Act introduces specific obligations for AI systems in medical devices, focusing on risk management, transparency, and data governance. Learn how manufacturers must adapt to ensure compliance and maintain CE marking under MDR and IVDR.
How much does a Notified Body certification cost?
The cost of obtaining certification from a Notified Body varies widely depending on multiple factors, including the classification of the medical device, scope of assessment, and specific Notified Body fees. Here are some ballpark estimates.
How much does a Notified Body certification cost?
The cost of obtaining certification from a Notified Body varies widely depending on multiple factors, including the classification of the medical device, scope of assessment, and specific Notified Body fees. Here are some ballpark estimates.
Is liability insurance mandatory for medical device manufacturers in the EU?
Medical device manufacturers operating in the European Union must comply with strict regulatory requirements to ensure patient safety and product reliability. One key aspect of these obligations is liability for defective products.
Is liability insurance mandatory for medical device manufacturers in the EU?
Medical device manufacturers operating in the European Union must comply with strict regulatory requirements to ensure patient safety and product reliability. One key aspect of these obligations is liability for defective products.
Conformity assessment procedures under the MDR: Annex IX, Annex X, and Annex XI
The key conformity assessment procedures under MDR 2017/745, including Annex IX (Quality Management System), Annex X (Type Examination), and Annex XI (Product Conformity Verification). Learn when each annex applies and how manufacturers can ensure compliance for Class IIa, IIb, and III medical devices.
Conformity assessment procedures under the MDR: Annex IX, Annex X, and Annex XI
The key conformity assessment procedures under MDR 2017/745, including Annex IX (Quality Management System), Annex X (Type Examination), and Annex XI (Product Conformity Verification). Learn when each annex applies and how manufacturers can ensure compliance for Class IIa, IIb, and III medical devices.
How can small businesses get their medical devices approved in the EU?
If you’re a small business or startup looking to sell a medical device in the European Union, you might feel overwhelmed by all the regulations and paperwork. While the EU has strict rules for medical devices, they’re there to ensure safety and quality. With the right approach, even small companies can complete the process successfully. Let’s break it down step by step.
How can small businesses get their medical devices approved in the EU?
If you’re a small business or startup looking to sell a medical device in the European Union, you might feel overwhelmed by all the regulations and paperwork. While the EU has strict rules for medical devices, they’re there to ensure safety and quality. With the right approach, even small companies can complete the process successfully. Let’s break it down step by step.
Do I need a notified body for my medical device?
If you’re planning to sell a medical device in the European Union (EU), one of the first questions you’ll encounter is whether you need a Notified Body (NB) to assess and certify your product.
Do I need a notified body for my medical device?
If you’re planning to sell a medical device in the European Union (EU), one of the first questions you’ll encounter is whether you need a Notified Body (NB) to assess and certify your product.
Can I sell my medical device in the EU without a CE Mark?
One of the most critical requirements for selling a medical device in the EU is obtaining CE marking. However, are there any circumstances where a medical device can be sold in the EU without a CE mark? Let’s explore the legal framework and possible exceptions.
Can I sell my medical device in the EU without a CE Mark?
One of the most critical requirements for selling a medical device in the EU is obtaining CE marking. However, are there any circumstances where a medical device can be sold in the EU without a CE mark? Let’s explore the legal framework and possible exceptions.
Understanding MDR Annex IX. Conformity assessment based on a Quality Management System and Technical Documentation
MDR Annex IX outlines conformity assessment for medical devices through Quality Management System (QMS) evaluation and Technical Documentation review. Understand requirements for CE certification under MDR 2017/745.
Understanding MDR Annex IX. Conformity assessment based on a Quality Management System and Technical Documentation
MDR Annex IX outlines conformity assessment for medical devices through Quality Management System (QMS) evaluation and Technical Documentation review. Understand requirements for CE certification under MDR 2017/745.
What happens if a medical device fails? Explaining recalls, adverse event reporting, and how authorities protect patients in the EU
This article explains what happens when a medical device fails in the EU, including adverse event reporting, recalls, and regulatory measures to protect patient safety. Understand how manufacturers, healthcare professionals, and authorities respond to device failures under MDR and IVDR regulations.
What happens if a medical device fails? Explaining recalls, adverse event reporting, and how authorities protect patients in the EU
This article explains what happens when a medical device fails in the EU, including adverse event reporting, recalls, and regulatory measures to protect patient safety. Understand how manufacturers, healthcare professionals, and authorities respond to device failures under MDR and IVDR regulations.
Verification and validation of medical devices: the EU approach in simple words
Learn the key differences between verification and validation of medical devices, their role in regulatory compliance (MDR, IVDR), and how they ensure safety and effectiveness. Explore real-world examples and best practices.
Verification and validation of medical devices: the EU approach in simple words
Learn the key differences between verification and validation of medical devices, their role in regulatory compliance (MDR, IVDR), and how they ensure safety and effectiveness. Explore real-world examples and best practices.
Biological evaluation of medical devices in the EU
The biological evaluation process is not just about conducting tests; it follows a scientific risk-based approach that considers the interaction between the medical device and the human body throughout its entire lifecycle.
Biological evaluation of medical devices in the EU
The biological evaluation process is not just about conducting tests; it follows a scientific risk-based approach that considers the interaction between the medical device and the human body throughout its entire lifecycle.
Understanding MDA, MDN, MDS, and MDT codes in the context of MDR and IVDR
Learn how MDA, MDN, MDS, and MDT codes are used in MDR and IVDR regulatory processes. Understand their role in device classification, Notified Body assessments, and conformity audits to ensure compliance with EU medical device regulations.
Understanding MDA, MDN, MDS, and MDT codes in the context of MDR and IVDR
Learn how MDA, MDN, MDS, and MDT codes are used in MDR and IVDR regulatory processes. Understand their role in device classification, Notified Body assessments, and conformity audits to ensure compliance with EU medical device regulations.
Structuring a quality management system for medical device manufacturers in the EU
This article demonstrates how to structure a Quality Management System for medical device manufacturers in the EU. Discover the key components, including ISO 13485 compliance, MDR-specific requirements, and manufacturer-driven processes for regulatory success and operational excellence.
Structuring a quality management system for medical device manufacturers in the EU
This article demonstrates how to structure a Quality Management System for medical device manufacturers in the EU. Discover the key components, including ISO 13485 compliance, MDR-specific requirements, and manufacturer-driven processes for regulatory success and operational excellence.
Certification, approval, and CE-marking for class I sterile medical devices in the EU
The CE-marking process for Class I medical devices is generally much simpler compared to higher-risk classes. However, the moment you introduce sterility, things take a sharp turn. Unlike general Class I devices, which can often be self-certified, Class I sterile devices come with extra layers of scrutiny.
Certification, approval, and CE-marking for class I sterile medical devices in the EU
The CE-marking process for Class I medical devices is generally much simpler compared to higher-risk classes. However, the moment you introduce sterility, things take a sharp turn. Unlike general Class I devices, which can often be self-certified, Class I sterile devices come with extra layers of scrutiny.
Clinical evaluation for class I medical devices: process, challenges, and examples
MDR requires manufacturers of all medical devices to conduct a clinical evaluation, regardless of risk class. Clinical evaluation for class I devices follows the same structured approach as higher-risk devices but is often less complex due to the well-established nature of many class I products.
Clinical evaluation for class I medical devices: process, challenges, and examples
MDR requires manufacturers of all medical devices to conduct a clinical evaluation, regardless of risk class. Clinical evaluation for class I devices follows the same structured approach as higher-risk devices but is often less complex due to the well-established nature of many class I products.
How clinical investigations fit into the clinical evaluation process
Clinical evaluation and clinical investigations are deeply connected, but they’re not the same thing. Think of clinical evaluation as the bigger picture — a continuous process of collecting and analyzing clinical data to support the device’s safety and performance. Clinical investigations, on the other hand, are one of the ways to generate that data.
How clinical investigations fit into the clinical evaluation process
Clinical evaluation and clinical investigations are deeply connected, but they’re not the same thing. Think of clinical evaluation as the bigger picture — a continuous process of collecting and analyzing clinical data to support the device’s safety and performance. Clinical investigations, on the other hand, are one of the ways to generate that data.
Strategy for regulatory compliance under MDR - how to document it and demonstrate compliance to a notified body
Medical device manufacturers operating in the European Union must have a regulatory compliance strategy in place as required by Article 10(9a) of the MDR (EU 2017/745). This requirement isn’t just about having the right documentation — it’s about demonstrating a structured and proactive approach to compliance.
Strategy for regulatory compliance under MDR - how to document it and demonstrate compliance to a notified body
Medical device manufacturers operating in the European Union must have a regulatory compliance strategy in place as required by Article 10(9a) of the MDR (EU 2017/745). This requirement isn’t just about having the right documentation — it’s about demonstrating a structured and proactive approach to compliance.
Medical devices without a medical purpose: how MDR regulates aesthetic and non-medical products
Some products that do not have an intended medical purpose but function similarly to medical devices and pose similar risks are also regulated under the Medical Device Regulation (MDR) (EU 2017/745). These include aesthetic and cosmetic products, such as contact lenses, dermal fillers, and body modification implants.
Medical devices without a medical purpose: how MDR regulates aesthetic and non-medical products
Some products that do not have an intended medical purpose but function similarly to medical devices and pose similar risks are also regulated under the Medical Device Regulation (MDR) (EU 2017/745). These include aesthetic and cosmetic products, such as contact lenses, dermal fillers, and body modification implants.
