The essential requirements were a core element to prove conformity with

the MDD, now the general safety and performance requirements (GSPR) serve this purpose under the MDR. The requirements covered in annex I of the MDR have been formulated more precisely and thematically extended.


The general safety and performance requirements (GSPR) can be found in the MDR annex I. Due to its shortness or out of habit, the term “essential requirements” is still often used, although it is referred to the GSPR.


In a nutshell: this will change

To illustrate the extent of the change: the essential requirements of the MDD are divided into 2 chapters with only 13 sub items. Now with the MDR there are 3 chapters with 23 sub items. Thus, the changes by the MDR have not significantly shifted the approach, but the scope and the details of the requirements have increased considerably. The word count from the ER to the GSPR has almost doubled.

Besides enlarging upon some aspects, other topics were newly incorporated in the requirements list of the GSPR. These include among others:

  • Requirements for devices that administer (GSPR 10.3/4) or contain drugs (GSPR 12)
  • Specific requirements for devices that contain tissues of human or animal origin (GSPR 13)
  • Requirements for disposal (GSPR 14.7/23.4)
  • Requirements for IT safety (GSPR 17.4)
  • Requirements for devices for use by lay persons (GSPR 22)
  • General requirements for labelling (GSPR 23)

Additional requirements also come from the fact that the MDD merges with the AIMDD (GSPR 19). Further, in the MDR’s GSPR a number of topics have been given greater emphasis or have been dealt with in more detail.


Layout and structure

The general safety and performance requirements are divided into the following chapters with their respective paragraphs:

1. General requirements

  1. Intended purpose, safety of patients, users and other persons
  2. Reduction of risks
  3. Risk management system
  4. Risk control measures
  5. Risks related to use error
  6. Device performance shall not be adversely affected
  7. Device design, manufacture, packaging
  8. Risk reduction, acceptable risk-benefit ratio
  9. General safety requirements also for devices referred to in annex XVI


2. Requirements regarding design and manufacture

  1. Chemical, physical and biological properties
  2. Infection and microbial contamination
  3. Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances/substance combinations that are absorbed by or locally dispersed in the human body
  4. Devices incorporating materials of biological origin
  5. Construction of devices and interaction with their environment
  6. Devices with a diagnostic and measuring function
  7. Protection against radiation
  8. Electronic programmable systems – devices that incorporate electronic programmable systems and software that are devices in themselves
  9. Active devices and devices connected to them
  10. Particular requirements for active implantable devices
  11. Protection against mechanical and thermal risks
  12. Protection against the risks posed to the patient or user by devices supplying energy or substances
  13. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons


3. Requirements regarding the information supplied with the device

  1. Label and instructions for use


Chapter 1 still shows several similarities with the MDD. Individual paragraphs comply more with it, however they put more emphasis on aspects such as usability, dependability along the product life cycle and the state of the art. Paragraphs 2 – 5 clearly stress the topic of risk management, meaning it is essential for medical devices. While paragraph 9 deals with new aspects concerning medical devices without an intended medical purpose, the other paragraphs are very similar to the MDD and depict the “standard” requirements for every medical device.

Some important parts from chapter 2 need to be highlighted, too. Concerning the chemical, physical and biological properties (paragraph 10) much more details are given, especially in terms of the handling of toxicity and specific substances. Further requirements on infection and microbial contamination are given in paragraph 11. The scope of medical substances has been extended in paragraph 12, so that now substances are included which are absorbed or locally dispersed by the human body. Similar is the case for biological tissue (paragraph 13), where human tissue (non-viable) is now also included. There are also more regulations for the interaction of medical devices with the environment (paragraph 14) and the compatibility with other devices. It is also necessary to note that the aspect of network security is becoming more important. Regulations for mechanical and thermal risks as well as risk reduction have become more detailed.

In chapter 3, paragraph 23 “label and instructions for use” is covered in detail. In general, it handles significantly more requirements, such as the format of the instructions for use, readability, comprehensibility, availability and all this in connection with lay persons as well – not only professionals. There are also many specifications with regard to the labelling of medical devices. Additional requirements must be fulfilled for UDI labelling as well as for devices containing human or animal tissue. The same applies to the labelling of sterile packaging or the indication of CMR substances. Thus, it can be stated that the requirements on labelling are changed in general and have increased considerably.


Some more facts

From a regulatory point of view there has been no fundamental shift in the position of the GSPR. It is still crucial that the safety and performance of medical devices are proved. This must be acceptable within the given clinical context. In addition, it must be ensured that these two components do not change significantly during the entire life cycle of the medical device. That is why a systematic risk management process is required, which must be updated constantly, even after the placing on the market.

The objective evidence that the GSPR are fulfilled is part of the technical documentation. Also, during the selected conformity assessment procedure, it must be proven that the GSPR are fulfilled.

They also react to current developments or topics which have been controversial in recent past. These include substance-based medical devices, software systems and special IT subjects or applications in homecare.

But there is one challenge with the GSPR: many state-of-the-art requirements from harmonised standards have been incorporated directly into the MDR. However, currently no annex Zx from the harmonised standards refers to the GSPR in the MDR. Meaning, that the link between the two still needs to be established by everyone themselves, thus there is no uniformity.


To be continued

Medical device manufacturers should quickly prepare and complete a new check list for the general safety and performance requirements according to annex I of the MDR. That way it can be ensured within the company that the new GSPR are implemented and complied with in time. Acting based on a check list is also practicable, for no one, not even the notified bodies, has yet had experience in interpreting the GSPR. This in turn means that an early consultation with a notified body is recommended, in order to identify any obstacle in time and to avoid it then.

The seleon gmbh can assist you with great knowledge, so that the MDR’s GSPR are fulfilled by your medical device and nothing will stand in the way of the next step, the conformity assessment procedure.


Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.