Newsletter No 12 March 2020

Subject: Essential requirements – what makes a medical device?

How to define a medical product? It ́s not only by the definition itself or by the purpose.
To call a product a medical device, we need more than the intended use.

One of the MDR annex offers a checklist called GENERAL SAFETY AND PERFORMANCE REQUIREMENTS instead of essential requirements in the MDD. The change of the name was based on the concept of increasing the safety of all medical devices.

When taking a first look at all these questions you might start thinking, this does not fit to my product. Why should I answer these questions? Please bear in mind, this annex was designed as a checklist to see if every aspect of the product is covered but also as an introduction to everyone who is not familiar with your product, like the Notified Body, during the product approval phase. The complexity is the reason that this annex can cover all medical devices from a pair of tweezers as well as plasters, brackets, syringes, X-ray machines or medical laser.

Let ́s take a closer look into this annex. This annex was built like a questionnaire with YES / NO responses. During the MDD often only the YES option was required for more detailed information, but now both options need a detailed explanation, why it applies or does not apply to my product.

Please remember the meaning of an introduction. YES will require a description of the processes involved and the relevant documents. NO should be followed by a brief explanation, why it does not fit to the product. Nevertheless, brief could also be short, when talking about a bracket an answer like; a bracket does not have an electrical plug would be enough explanation for a NO.

Before starting to answer the questionnaire, a good preparation is needed. On the one hand, not only because a lot of information about the product itself is required, but also information about possible combinations, side effects, possible methods of sterilisation and so on. It is a good idea to take a close look at the usability and risk analysis documents.

The annex contains three major chapters with different subchapters:

The first chapter was called general requirements and deals with the production process, the minimisation of the product risks side effects and general safety aspects of the product. Your risk management and usability processes provide all the requested information for this chapter. Although the development phases and their validation and verification are useful for a process overview. Answering YES to each question is mandatory. No one wants a medical device that is not delivering the wanted performance or ignoring safety aspects.

Chapter 2 deals with the requirements regarding design and manufacturing and includes the following subchapters:

  • Chemical, physical and biological properties
  • Labeling of hazard substances
  • Infection and microbial contamination
  • Devices incorporating materials of biological origin
  • Devices with a diagnostic or measuring function
  • Protection against radiation
  • Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
  • Active devices and devices connected to them
  • Specific requirements for active implantable devices
  • Protection against mechanical and thermal risks
  • Protection against the risks posed to the patient or user by devices supplying energy or substances
  • Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

I would introduce shortly most of these points, although the most are self-declaring to the user.

Chemical, physical and biological properties and the labeling of hazard substances:

Some products may contain raw materials with possible hazardous substances like softener (phthalates), sensitizer (latex, Chromium, Nickel) or unwanted glues (Bisphenol A). Identification and labeling will minimize the risks of allergic reaction to the patient and the user. Second step could be a replacement in the raw materials to avoid such substances in general.
Infection and microbial contamination:
This is not only about microbial contamination of the product but also about the usability of the product. Avoid sharp edges and all details that may hurt user and patient especially after the use. Please make sure that the scalpel could be stored safely during the surgery to protect everyone involved.

Devices incorporating materials of biological origin:

If your product contains blood or parts of blood, you know the detailed answers for this question.

Devices with a diagnostic or measuring function:

This subchapter is very important, because a medical device with measuring function could even be a thermometer. Measuring function means providing information about the patient like temperature, blood pressure value etc. Working with such a device needs covering calibration steps, sometimes software checks and so on.

Protection against radiation:

If your device works with a radiation source, the development and risk management files provide the required information.

Electronic programmable systems: Devices that incorporate electronic.

Programmable systems and software that are devices in themselves:

A new point of interest in the MDR. According to the technical development software and programmable system getting more and more important in the medical industry and for the treatment of patients. The development and usability documents will provide all needed information in detail.

Active devices and devices connected to them:

Due to the vast range of active medical devices, the concept of risk assessment and risk minimisation based in the MDR was divided into the subchapters:

a) Protection against mechanical and thermal risks
b) Protection against the risks posed to the patient or user by devices supplying energy or substance
c) Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

In these three subchapters, all the aspects of active medical devices are covered. It does not matter if the questions may fit to an electrical thermometer with a single battery or to a magnetic resonance tomography. The requested information will be provided in the development documents.

Specific requirements for active implantable devices:

Following the breast implant scandal some years ago, implantable devices and especially the active ones became of more interests. Based on the safety concept the MDR requires information that is more detailed.

Chapter 3 referring to the information supplied with the device to the customer. It contains only labelling and instruction for use, but in a very detailed way. This chapter could be used as a checklist to see what is required for my product and does my label meet all requirements. It is useful to know who will work with the product. Most of the information should be available from the development files. In detail the e.g. point 23.2 is an ideal checklist for creating a possible label. It states what is required for a label and just check if this fits to your product. If NO ignore this part of the label, if YES just add this part to you own label. This very detailed chapter for labelling is also part of the new safety concept of the MDR.
As a conclusion the essential requirement in the annex one, of the MDR covers the safety concept, the risk and usability management, technical performance and the correct labelling including UDI.
As you can see, the essential requirements are extremely important to give a short, but detailed explanation of your medical device. They define the performance of the product and gives an overview of possible risks. All the processes the company made to minimize potential risks were mentioned in this document.

STS group provides the essential requirements in detailed version, considering raw material specifications, technical characteristics and process details. Not forgetting risk and usability management for the balance between possible risk and the benefit for the patient. Therefore, a complete and detailed filled essential requirement document is part of the successful medical device approval process involving Notified Bodies and National Authorities.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We are already today all dependent on an effective cooperation. For the MDR implementation, we require even a closer collaboration in order to ensure we all can deliver safe supply to hospitals and patients in the future. We are confident we will be able to continue to supply health care competently on customized surgical procedure sets and small kits.

The next MDR Newsletter will be issued in April. We wish everybody pleasant days.

You want to know more about specific topics?  Do you have any questions or comments?  Write us!

Augusto Orsini
CEO STS Medical Group

Dr. Sönke Asmussen
Group Manager
for Quality System Compliance