The EU medical device regulations (MDR and IVDR) refer to the requirements that every medical device must meet as General Safety and Performance Requirements (GSPR).
The previous Medical Device Directive (MDD) referred to the “general requirements”.
Content
On this page, you will find references to relevant articles.
The MDR and IVDR list the General Safety and Performance Requirements in their respective Annexes I. Examples of GSPR are:
The GSPR do not depend on the class of the medical device.
The manufacturers themselves provide proof that the medical devices meet these general requirements as part of a conformity assessment procedure. Depending on this conformity assessment procedure, they have to involve notified bodies.
Manufacturers often use harmonized standards to prove conformity with the General Safety and Performance Requirements.
The MDR and IVDR also require compliance with so-called common specifications.
As a manufacturer, you must demonstrate conformity precisely and sentence by sentence. You can benefit from our checklists such as the MDR checklist.
The MDR and IVDR formulate the requirements more granularly than the MDD respectively the IVD did and have expanded them. In addition, the MDR and IVDR distinguish between the “General Safety and Performance Requirements” (Annex I) and the requirements and their verification in the technical documentation (Annex II).
Compared to the MDD, the MDR also explicitly sets out requirements for:
Do you still have questions about the basic requirements for medical devices? Then, benefit from free micro-consulting.
The Johner Institute supports medical device manufacturers,
Contact us! The Johner Institut team will be happy to assist you!
In 21 CFR part 11, the FDA establishes its requirements for electronic records and signatures, which also apply to medical device manufacturers. A lot of companies print everything out on paper and then sign it by hand to circumvent the requirements of part 11. Is this really necessary?
DetailsPDMS stands for patient data management system. These clinical information systems are typically used in hospitals, especially in departments that treat patients in intensive care. PMDS are experiencing a new boom in Germany as a result of the funding provided by the Hospital Future Act (Krankenhaus-Zukunftsgesetz, KHZG). This article provides
DetailsThis article outlines the five most common misconceptions and mistakes medical device manufacturers should avoid during clinical evaluation and how to avoid them.
What is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article
DetailsThe ISO 10993-17 standard is part of the ISO 10993 series of standards on biocompatibility. ISO 10993-17 describes the procedures for Toxicological Risk Assessment. In the fall of 2023, a comprehensive standard revision was published after over 20 years. Medical device manufacturers should know, This article will help.
DetailsThe qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and what costs arise for “approval.” This article will help you correctly qualify and classify IVD software, thereby avoiding regulatory problems and the resulting costs and delays.
DetailsIn vitro diagnostic medical devices (IVDs) are medical devices used to analyze samples derived from the human body. Typically, these products are reagents, kits, instruments, and devices. Software can also be considered as an IVD regarding its intended purpose. When “approving IVDs,” manufacturers must comply with many regulations, laws, and standards.
DetailsIncluding a free download of the chapter structure for the Clinical Evaluation Plan The Clinical Evaluation Plan is one of the most complex documents in the technical documentation. Alongside the Clinical Evaluation Report, the Clinical Evaluation Plan (CEP) is the document most frequently criticized by notified bodies. Even experienced clinical experts typically need 60 working…
DetailsDirective 2014/53/EU (Radio Equipment Directive (RED)) applies to devices that use Wi-Fi or RFID, for example. Medical devices that send a radio signal because they connect to the internet or are operated remotely also need to demonstrate conformity with the RED before being marketed. In this article, learn more about
DetailsLaws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always sufficient to meet these requirements. In particular, medical device manufacturers who do not supply and use SBOMs for their software are no longer accepted in the market. Here are the reasons.
Details
Privacy Preference
We need your consent before you can continue on our website. If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. You can revoke or adjust your selection at any time under Settings.
Privacy Preference
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.