Preview
CE-Certificate vs. EC-Certificate
Among medical device and IVD manufacturers, there is a belief that a CE-certificate is required to bring their products to the European market. Sometimes, however, there is mention of an EC-certificate: supposedly, this is what's needed to sell medical devices in the EU. Does this mean two certificates are necessary? Or is one of them sufficient? Perhaps, these are two names for the same certificate?
This article will help clarify European certificates for medical devices.
What is a CE-Certificate?
The most important thing to know about a CE-Certificate is that it doesn't actually exist (the CE Mark exists, but the CE Certificate does not). When referring to a CE-Certificate, one might be referring to one of the following documents: an EC-Certificate (in reality, this term is also not entirely accurate - see below), an EU Declaration of Conformity, or...
Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it
With the introduction of European regulations MDR and IVDR, governing the circulation of medical devices in the European Union, a set of requirements emerged, compliance with which is necessary for manufacturers wishing to distribute their medical products in Europe. Basic UDI-DI (bUDI) is one such requirement. In this article, we will explore what the basic UDI-DI entails, how it can be obtained, and how it should be utilised.
What is Basic UDI-DI (bUDI-DI)
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. The necessity to obtain and use the basic UDI-DI identifier is regulated by...
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.
What is EUDAMED
EUDAMED is the unified information system of the European Union for medical devices and organizations that are involved in the placement and circulation of medical devices on the EU market. Registration in the Eudamed system is a requirement of EU Regulation MDR 2017/745 (Articles 29-31 para. 4) and EU Regulation IVDR 2017/746 (Articles 26-28 para. 3).
The system consists of six modules with the following functions:
- Registration of economic operators
- Registration of medical...
Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)
The Authorised Representative in the EU (AR, EC REP) plays a crucial role for medical device companies located outside the European Union and seek to sell their products within the EU territory.
The requirement for having an Authorised Representative is outlined in both European regulations: in the Medical Devices Regulation (MDR) and in the In Vitro Diagnostic Medical Devices Regulation (IVDR). Each of the regulations dedicates a separate article to the Authorised Representative, namely, Article 11.
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. The mandate has some characteristics that distinguish it from other contracts.
Below, we will discuss these characteristics and what should be included in the agreement with the Authorised Representative...
GSPR – General Safety and Performance Requirements for medical devices in the European Union
GSPR (General Safety and Performance Requirements) is a central concept in European legislation for medical devices, laying down fundamental principles for the regulation of medical products in the European Union. As the name suggests, GSPR comprises a set of requirements regarding the safety and performance of medical devices placed on the European market.
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.
Considering the essence of these requirements, it becomes evident that GSPR forms the basis of the primary regulations of the European Union concerning medical devices, namely MDR 2017/745 and IVDR 2017/746. In essence, it can be stated that the ultimate goal of MDR and IVDR is to ensure that every medical device introduced to the EU market complies with GSPR...
How to obtain CE marking for medical software under the EU MDR or IVDR?
Medical Device Software (MDSW) refers to software applications that are an integral part of a medical device or intended for use in the diagnosis, monitoring, treatment, or prevention of diseases. These software systems play a crucial role in modern healthcare, facilitating tasks such as data analysis, image processing, treatment planning, and more.
However, due to their critical impact on patient safety and health outcomes, MDSW is subject to rigorous regulatory requirements to ensure their reliability, accuracy, and compliance with medical standards. This includes adherence to the European Union's Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) for devices marketed in the EU. Understanding and meeting these regulatory standards is essential for manufacturers and developers of MDSW and necessary for obtaining the CE-marking demonstrating product's regulatory compliance...
Technical documentation for Medical Device Software in the EU
Medical Device Software (MDSW) stands at the forefront of innovation in modern healthcare. From diagnostic tools to treatment planning and monitoring, MDSW has revolutionised patient care. However, it's important to remember that, like any other medical device, MDSW requires technical documentation.
Technical documentation is a universal requirement for all types of medical devices, including MDSW
Ensuring compliance with MDR or IVDR is a fundamental aspect of bringing any medical device to market. Medical Device Software (MDSW), although intangible, shares this imperative.
Technical documentation serves as the backbone of regulatory compliance and quality assurance. It encapsulates the entire lifecycle of the software, from its conception to its deployment in clinical settings...
IEC 62304 - the pivotal standard for software medical devices
IEC 62304, titled "Medical device software - Software life cycle processes," is an international standard that outlines the requirements for the development, maintenance, and support of medical device software. It provides a structured framework for managing the entire lifecycle of software used in medical devices or stand-alone medical software. Adhering to IEC 62304 is critical for medical device 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.
For those well-versed in ISO 13485 and ISO 14971, delving into IEC 62304 might initially feel disorienting. Conversely, individuals from computer engineering backgrounds, with a solid understanding of software lifecycles, may find certain sections of IEC 62304 confusing.
The thing is, IEC 62304 demands proficiency in two distinct domains: the world of computer engineering, where concepts like...
Medical Device Regulation (MDR) - basics
The Medical Device Regulation (EU) 2017/745 (or simply MDR) is a complex and comprehensive document, and it plays a central role in the regulation of medical devices within the EU. It sets high standards for safety and performance and aims to ensure that medical devices meet the needs of patients while minimizing risks. Compliance with the MDR is essential for manufacturers looking to market their devices in the EU.
What is MDR?
The MDR is a set of regulatory guidelines established by the European Union to ensure the safety, quality, and performance of medical devices. It replaces the Medical Device Directive (MDD) and places greater emphasis on patient safety, transparency, and traceability throughout the entire lifecycle of a medical device...
ISO and IEC standards for medical device software
The ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) have established a set of standards governing the development, quality, and safety of medical device software (MDSW). These standards provide a structured framework for manufacturers to ensure that their software meets the standards of reliability, safety, and performance.
General medical device standards
Two ISO standards play a crucial role in the realm of software medical devices: ISO 13485 and ISO 14971. Considered as the cornerstone standards for medical devices, they hold relevance across the entire spectrum of healthcare products, from basic plasters to intricate surgical robots. Despite their comprehensive nature, they don't specifically address software...
Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle
Clinical evaluation stands as a cornerstone in ensuring the safety and performance of medical devices throughout their lifecycle. This process involves the systematic assessment of clinical data to establish and confirm the device's clinical safety and performance.
Clinical evaluation is not just a best practice but a regulatory requirement under the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It serves as a critical component for obtaining and maintaining CE marking.
PMCF is an extension of the clinical evaluation process. It involves the systematic collection and evaluation of clinical data on a medical device after it has been placed on the market. The insights gained from PMCF activities help confirm the continued safety and performance of the device in real-world scenarios...
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.
Notified Bodies play a pivotal role in ensuring that medical devices placed on the market meet the necessary safety and performance standards. Their assessments contribute to the overall regulatory framework for medical devices in the EU.
Where do Notified Bodies come from?
The designation of Notified Bodies in the European Union is a complex and regulated process.
The process begins with a Notified Body applying to the National Competent Authority (NCA) of an EU member state for designation. The NCA is the regulatory body responsible for medical devices in each member state...
What is NANDO and why medical device companies should know about it?
NANDO, which stands for New Approach Notified and Designated Organisations, is a central and official database maintained by the European Commission. It plays an important role in providing public access to information about organizations designated and notified under the New Approach Directives and Regulations in the European Union.
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.
In other words, NANDO is a place where you can find a Notified Body that will certify your products.
What information you can find in NANDO
NANDO serves as a comprehensive and centralised repository for information on Notified Bodies in the EU. It includes details on organizations...
Labeling and UDI requirements for medical devices in the EU
The labeling and Unique Device Identification (UDI) requirements for medical devices in the European Union are outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
These requirements are designed to enhance traceability, transparency, and post-market surveillance of medical devices in the EU. Manufacturers should carefully review the specific requirements of the MDR or IVDR applicable to their devices and ensure compliance with labeling and UDI obligations.
Medical device labeling requirements
There isn’t a one-size-fits-all format for a great medical device label. The required elements will vary depending on many factors. It’s up to the manufacturer to ensure that all of the necessary elements are included, and that the label succeeds in conveying the information needed by the patient to have a ....
Understanding the roles of Authorised Representatives and Importers under MDR/IVDR
The implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the European Union (EU) has introduced a comprehensive framework for the regulation of medical devices and in vitro diagnostic medical devices. Two important actors in this regulatory landscape are Authorised Representatives (ARs) and Importers, each playing distinct yet crucial roles in ensuring compliance and safety.
Authorised Representatives
Articles 11 of the MDR and IVDR outline the essential functions and responsibilities of Authorised Representatives...
MDR implementation - challenges and solutions
Implementing Medical Device Regulation (MDR)-compliant documentation and Quality Management Systems (QMS) poses various challenges for manufacturers. From stringent clinical evidence requirements to the intricacies of Unique Device Identification and heightened scrutiny from Notified Bodies, the road to MDR compliance is laden with obstacles.
By approaching each challenge strategically, manufacturers can enhance their readiness for MDR compliance. It's crucial to adopt a proactive mindset, stay informed about regulatory updates, and collaborate with relevant stakeholders throughout the implementation process. Regularly reassess and adapt strategies as needed to navigate the evolving regulatory landscape effectively.
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...
Post-market surveillance under MDR and IVDR - requirements and best practices
With the new European medical device legislation, the post-market surveillance (PMS) requirements outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have taken center stage. Manufacturers now face an enhanced focus on continuous monitoring, reporting, and improvement of their products throughout their lifecycle.
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.
Key requirements
Under the new regulations, manufacturers are required...
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.
Getting ready for these audits is not just about formally meeting regulatory standards but about showcasing a robust and in many cases scientifically sound approach to demonstrate medical device's safety and effectiveness.
Documentation
The initial step in a Notified Body audit involves reviewing technical and Quality Management System (QMS) documentation. Therefore, prior to the audit, it's crucial to prepare documentation of the highest quality. This documentation...
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. The risk management plan shall be a part of the risk management file, which is a part of the Technical Documentation.
The purpose of a Risk management plan is to describe the process to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls according to ISO 14971:2019 and ISO TR 24971:2020.
The Risk management plan applies to all stages of the product life-cycle including all activities such as design, verification, validation, production and post-market activities...
Should my medical device comply with GDPR?
In today's interconnected world, where technology intersects with healthcare, regulations intersect as well. As innovative solutions emerge to enhance patient care and treatment outcomes, regulatory frameworks evolve to ensure their safety, efficacy, and compliance with data protection standards. From medical devices integrated with digital health platforms to mobile health applications collecting health data, the convergence of technology and healthcare demands a harmonised approach to regulation.
GDPR and MDR/IVDR
The General Data Protection Regulation (GDPR) stands as a cornerstone in safeguarding personal data privacy, while the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) set forth standards for the safety and performance of medical devices. However, when a product bridges both realms serving as a medical device while simultaneously collecting and handling personal data...
EC-certificate for a medical device - Q&A
1. Is EC-certificate a valid term?
It is rather medical device lingo than a valid term. While the term "EC certificate" is commonly used within the context of medical devices in the European Union, it's important to note that it's not a valid term recognised by the relevant legislation, such as the Medical Device Regulation (MDR) or other applicable directives.
The term "EC certificate" is colloquially used by medical device professionals to refer to the certificate issued by a Notified Body following audit and inspection.
However, due to its widespread usage and acceptance within the industry and because it is less wordy, we will continue to use the term "EC certificate" below.
2. Is EC-certificate required to sell a medical device in the EU?
Yes. The EC-certificate indicates that the medical device has undergone the necessary conformity assessment by a Notified Body for certain classes of devices, and that it meets the requirements for safety, performance, and...
How long does it take to CE-mark a medical device?
For any medical device company venturing into the European market, obtaining a CE mark is often a top priority. It's a crucial step toward gaining access to the vast EU market and selling there their products.
The question of how long it will take to obtain CE marking is one of the first, if not the very first, inquiries that companies have. Unfortunately, providing a definitive answer to this question is exceedingly challenging due to the multitude of factors at play.
The CE marking process is intricate and multifaceted, encompassing various stages such as conformity assessment, documentation preparation, and engagement with Notified Bodies. The duration of each stage can vary significantly based on factors like the device classification, complexity, and the thoroughness of documentation. Moreover, the availability and workload of Notified Bodies, who assess device conformity, can also impact timelines...
What is a PRRC?
PRRC, or Person Responsible for Regulatory Compliance, is an essential role introduced under the EU Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746). These regulations mandate that companies appoint a qualified regulatory expert, known as a PRRC, to oversee compliance with regulatory requirements.
Why do I need a PRRC?
It's a legal requirement laid down in MDR and IVDR. 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. Authorised Representatives (AR) are also required to have a PRRC available permanently and continuously. The PRRC must possess appropriate expertise and qualifications in the field of medical devices or IVDs, as applicable...
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. Understanding the difference between these two roles is key to complying with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Importers are defined as any natural or legal person established within the EU who places a device from a third country (non-EU country) on the EU market. In other words, importers are responsible for bringing medical devices from outside the EU into the Union market...
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 — the label, instructions for use, implant cards, or any other relevant materials — must be in the official language(s) of the EU Member State where the device is being made available. This ensures that users, whether patients or healthcare professionals, can easily understand and safely use the device. No complex interpretations or guesswork required — just ensure the information is accessible in the accepted language of the country, and you’re good to go.
In some EU countries though, labels and Instructions for use can be provided either in the national language(s) or in English, if the device is intended for use by medical professionals. Countries that allow this flexibility include Germany, Austria, Belgium, Cyprus, Estonia, Ireland, Malta, Poland, and the Netherlands. Meanwhile, other countries like Finland, Denmark, Latvia, Romania...
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 leverage the expertise and resources of specialized manufacturers while maintaining control over product oversight and compliance. This model streamlines production processes and facilitates quicker access to markets.
It’s important to clarify that, officially, the terms Legal Manufacturer and Original Equipment Manufacturer do not appear in the MDR or IVDR. These definitions are not formally recognized in the regulatory texts. However, they are widely used colloquially by professionals in the medical device industry.
How to structure a PRRC contract for effective compliance
If you’re involved in the world of medical devices, you know that having a Person Responsible for Regulatory Compliance (PRRC) is essential for meeting EU regulations. The Medical Device Regulation (MDR) and In Vitro Diganostic Regulation (IVDR) both have specific requirements for this role laid out in Article 15 of both regulations, and a contract with your PRRC is important for staying compliant. But while it’s essential to meet these regulatory requirements, the contract with the PRRC can also be customized to fit your company’s unique needs. Here’s how to balance compliance with flexibility.
Following Article 15 MDR or IVDR
The requirements for a PRRC are nearly identical in both the MDR and IVDR...
How to Create a Declaration of Conformity According to MDR or IVDR
Creating a Declaration of Conformity (DoC) is an essential step for manufacturers of medical devices and in vitro diagnostic devices who wish to enter the European Union market. The DoC is an official document that confirms your device complies with all the requirements outlined in the MDR or IVDR. Here's a guide on how to create a DoC in line with these regulations.
The requirements for a Declaration of Conformity under both the MDR and IVDR are quite similar and are outlined in Annex IV of each regulation. This annex details the essential elements that must be included in the DoC.
