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DetailsIn vitro diagnostic medical devices or in vitro diagnostics (IVDs) are a subgroup of medical devices. IVDs obtain medical information from human samples. Their clinical benefit lies in providing precise, accurate, and correct information to support or to make a diagnosis.
Content
This page gives you a quick overview of the regulatory requirements for in vitro diagnostics:
- Definition of an in vitro diagnostic medical device
- Regulatory requirements for IVDs
- Particular requirements for specific IVDs
- Support for IVD manufacturers and laboratories
1. Definition IVD
a) Definition in Europe
The EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) defines what an in vitro diagnostic medical device is:
Definition: In vitro diagnostic medical device
means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;
Source: IVDR, Article 2
b) Definition of the FDA
The FDA’s definition is similar:
Definition: In vitro diagnostic product
In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.
Source: 21 CFR 809.3 (a)
2. Regulatory requirements for IVDs
a) Regulatory frameworks
In Europe, manufacturers, importers, and distributors of in vitro diagnostics must comply with the IVDR. You should be aware of the differences between the IVDR and IVDD.
Depending on the product type, other EU regulations, common specifications, or EU directives (e.g., the Machinery Directive) may be relevant for an IVD.
The FDA has its requirements for placing IVDs on the market.
b) Approval
The following articles provide the necessary expert knowledge for the approval of in vitro diagnostics:
- Overview of the approval of IVDs (in vitro diagnostics)
- Classification of in vitro diagnostics
- Classification of IVD software
- 7 steps to a medical device
- Harmonized standards for the verification of general safety and performance requirements
c) Requirements to be verified
To be allowed to place IVDs on the market in Europe and other markets, these devices must meet requirements. These include the General Safety and Performance Requirements set out in Annex I of the IVDR, as well as requirements relating to
- the intended purpose of the device,
- the development process,
- the risk management,
- the verification and validation,
- the performance evaluation of IVDs, which may require sample size planning and the anonymization and pseudonymization of personal data,
- usability, including instructions for use, and other labeling,
- electrical safety and electromagnetic compatibility (as formulated in IEC 61010-2-101).
d) Further requirements
In addition, manufacturers must ensure that, for example
- they have implemented a quality management system in accordance with ISO 13485,
- have a responsible person (PRRC),
- assign a Unique Device Identification (UDI) for their devices,
- register themselves and their devices in the EUDAMED,
- validate their production processes,
- carry out the necessary post-market surveillance activities and implement vigilance processes.
3. Particular requirements for specific IVDs
Specific IVDs must meet particular requirements. These articles provide an overview:
- Devices for self-testing and near-patient tests
- Companion Diagnostics (CDx)
- In-house IVD (formerly Laboratory Developed Tests, LDTs)
- Sampling kits
If the devices contain software or qualify as IVD software, the following articles are helpful:
- Software as medical device
- Qualification and classification of IVD software
- IVD software manufacturers take note
- Regulatory requirements for medical devices with machine learning
- Parameterization of software
- Decision support systems as medical devices
4. Support for IVD manufacturers and medical laboratories
a) Free support offers
Do you still have questions about in vitro diagnostics and the regulatory requirements? You can get answers in our free micro-consulting.
Download the free starter kit, which will give you an overview of the regulatory landscape and show you the steps to get your IVD “approved.” It also contains the IVDR checklist in PDF and DOCX format!
b) Videos and e-learning
The video training courses at the Medical Device University show you how to create your technical documentation and your QM system lean, fast, and IVDR-compliant. Over 100 templates and sample documents are available for you to download.
This will enable you to create the prerequisites for approving your devices quickly and safely and launching them on the market.
c) Seminars
Some of our seminars are aimed specifically at IVD manufacturers and laboratories.
d) Product tests
The experts at the Johner Institute will help you test your devices:
- Usability tests
- Penetration tests
- Electrical safety and EMC tests
- Performance evaluations
e) Consulting and support
The Johner Institute experts will help you develop your devices in compliance with regulatory requirements and bring them to market. We can either assist you or take on some of the work.
Benefit from the regulatory affairs experts to help you
- determine your regulatory strategy and classify your devices,
- set up your quality management system,
- create the technical documentation,
- determine the product-specific performance evaluation strategy,
- check the technical documentation and QMS, prepare for and accompany audits and reviews, and
- to take over post-market surveillance.
Contact us now to clarify together how you can quickly and efficiently meet the regulatory requirements of the IVDR and get your devices safely to the market.
Regulatory requirements for medical devices with machine learning
Manufacturers who use machine learning (ML) in their medical devices or IVDs must comply with numerous regulatory requirements. This article provides an overview of the most important regulations and best practices for implementation. It saves you the trouble of researching and reading hundreds of pages and helps you prepare perfectly for your next audit.
DetailsWhat the AI Act means for medical device and IVD manufacturers
The EU AI Act has been published. Many manufacturers of medical devices and IVD, as well as other healthcare players, are faced with the major task of understanding the 140+ pages of legal text and complying with the requirements. Note: Infringements/violations of the AI Act are punishable by a fine of up to 7% of…
DetailsClassification of in-vitro diagnostic medical devices: how to avoid a too-high classification
The classification of in-vitro diagnostics (IVD) can have far-reaching consequences, as it has an impact on the conformity assessment procedure, certification audits, and, thus, on market launch. To help you prevent the unnecessary allocation of your IVD product to a high-risk class, this article provides an overview of
DetailsIntended purpose and intended use: More consequences than you think!
The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the connection between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
DetailsIEC 61010-1 and IEC 61010-2-101: Requirements for IVD medical devices
The IEC 61010 series of standards specifies safety requirements for electrical equipment used for measurement, control, regulation, and laboratory use. The general standard IEC 61010-1 and the particular standards of the IEC 61010-2 series describe the state of the art and thus serve IVD manufacturers as a means of demonstrating compliance with the general safety…
DetailsSoftware as Medical Device
Software as medical device (SaMD) refers to (independent) standalone software that is a medical device but not part of one. It should not be confused with medical device software as defined by the EU. As a manufacturer, when do you have to qualify software as medical device, and when as medical device software? Find out…
DetailsHarmonized standards: Evidence for medical device manufacturers
Most manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example.
ISO 15189 for medical laboratories
The ISO 15189 standard “Medical laboratories – Requirements for quality and competence” specifies the requirements for a quality management system for medical laboratories. Laboratories are legally obliged to establish a QM system. According to ISO 15189, laboratories that operate in-house IVD medical devices require a QM system, which must be extended by additional chapters. This…
DetailsClinical validation: A definition
The term “clinical validation” is also frequently used in the context of medical devices. For example, the German Federal Ministry of Education and Research (BMBF) has published a guideline on the clinical validation of innovative medical technology solutions (only available in German). The FDA also refers to clinical validation. What is clinical validation? What distinguishes…
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