New guidelines for CE
There is a new category of devices that are indicated in the new regulation as medical devices that were not explicitly mentioned in the old directive. Basically, one of the definitions of a medical device is that it needs to have a medical purpose.
EU regulatory bodies have issued new guidelines that will take effect from 2021. These guidelines mainly concern medical devices. According to the new guidelines, medical devices were divided into four categories as listed below: according to guidelines 93/42 / EEC and also EU 2017/74.
The criteria for classification according to the complexity of the device and the potential dangers to the patient. We will try to detail this later. In any case, the ISO 13485 quality standard is mandatory for every medical device.
For devices in the first category, the manufacturer's documentation (including the IFU user manual, the middle stage documentation, the production of a strict quality assurance system) is sufficient to apply for CE.
Devices in the other categories require external control, such as an approved laboratory and more. A regulatory agency can perform a pre-CE certification check for you. Such an agency will also check the reliability of the quality system to prove that inspections are carried out as required. This inspection will be carried out at least once a year. The purpose of the audit is to ensure that all the guidelines in ISO 13485 have been complied with and also the guidelines according to 93/42 / EEC
After checking which category your device belongs to it is advisable to perform the process in the steps listed here:
Step 1 of the process to CE mark a medical device: identifying the applicable directives/regulations
The device must have a medical purpose. Humans need to use it. There must be a designated medical purpose and it is meant to be used by humans. In this case, suppose it helps in the process of disability. If you have some heart rhythm problems, say, then it helps with a certain disability. In this case you will be able to identify a pacemaker as a medical device. You just have to find the rules that apply to your product. This way, you will be able to identify the classification of your products.
Do it yourself? Obviously you can also seek help from a consulting firm that will help you. Because basically, it's their job they always do on a daily basis. Not everyone works with the regulation of the medical device on a daily basis it is advisable to check the list of devices they have worked with in the past.
Step 2 of the process to CE mark a medical device: Determining the requirements and standards for medical devices
The Anex A appendix presents a long list of essential requirements. This list basically indicates the requirements that medical devices have to meet. The essential requirements are classified. For example pacemakers that depend on electrical currents or something like that which means if we are talking about pacemaker this part is applicable in the process of CE marking of a medical device to determine the requirements for both medical and electrical devices. In such cases you will find an overlap between standards.
Step 3 of the process to CE mark a medical device: Determining the route to conformity
If you have a Class I medical device, you as the manufacturer must make sure that your product is compatible. So you can bring it to market, after you have marked it CE, of course. If you have a type IIa medical device, you must also have an evaluation carried out by another party, which requires that you have proper technical documentation, and you need to implement a quality management system. Both things will be checked by the advisory agency. The agency will do a table test or table evaluation of the documentation and will have to check if all the documentation exists and if there is enough evidence to prove that your product meets the standard. They will also need to approve the quality management system used to manufacture your product. To that end they will do an on-site audit, and they will also repeat audit, say, once a year.
There is something you need to do yourself as a manufacturer. The advisory body does not always perform specific tests. They can test a particular module or test any product, but when you talk about serial production, it is very inefficient. In this case, basically what they will do is that they will check the documentation and issue a certificate if the documentation matches the requirments. They will also check the quality management system. However, when we talk about a Class III device, the advisory bodies will act more cautiously and ask for more information so that the overall review of the requirements remains the same, in the documentation requirements. However, the control should be more in-depth in case there are multiple risks to the product, and there should be some additional safety features to make sure they are compliant.
Step 4: How to test your medical device
The tests are part of the documentation, and really, and when you think about the technical documentation that encompasses quite a few aspects, it also encompasses test reports. Suppose that if the advisory body examines your technical documentation, then you will need to already have a number of inspection reports in accordance with certain standards. There is a separate route that you can choose from when an advisory body examines basically every single device. This is not a frequently chosen route because it is very inefficient when we talk about products produced in series.
Risk assessment is mandatory, according to the ISO 14971 risk management standard.
Basically, risk management is quite important because one should always check what the risks are related to the device, and how the risk actually affects patients or use or something else, because obviously if you are talking about the medical device, is it used to improve a particular patient's condition. There may be risks. However, are the improvements and the benefit are higher than the risk, it's fine, and that's basically the case for all products in the EU. There is always a risk. You can not eliminate the risks completely.
The machine instructions also require risk analysis for the machines, in accordance with ISO 12100
First of all, when there are certain risks associated with using machines, as a manufacturer, you need to make sure that the design is safer. It is not always possible to create a device that is 100% safe. Then there is the second step of risk reduction, which is the provision of safety measures, but still, there may be risks associated with the use of machinery. Then the last step, to reduce the risk, is by giving instructions for use.
Step 5: Compiling the technical file of your medical device
Suppose there is a change in design, then it can affect the patient, and it can impose, say, a new risk. This is a new document that is part of the technical documentation, and you should also check it with the advisory agency. If we talk, say, about the pacemaker and the advisory body makes an assessment of the documentation. However, it remains a document that needs to be updated if there are any changes to the device. Changes can actually recorded in the technical documentation cabinet, and be between the specific stages.
Step 6: Drafting the Declaration of Conformity
If the advisory body is also present in the compliance assessment process, it is interested in seeing an example of a declaration of conformity so that it can also check whether it complies with the requirements for a declaration of conformity. In fact, you have an unsigned one, and when you stick the CE label, you sign your declaration of conformity. The statement should include UDI-DI numbers.
This is a new element for regulating and tracking the medical device. To encourage the traceability of medical devices, as it is a unique number for medical CE devices. Not as unique as the serial number, because it is unique to each device. The UDI number is basically used to identify certain devices. It has been used in other parts of the world. For example, in the US they are already working with a UDI. Basically, what is the UDI, if we talk, say, the pacemaker, the pacemaker has a specific UDI that it detects a unique device. These, so the box itself has a different UDI number, and if you scan that UDI number, then you know it refers to a box of five pacemakers from the same manufacturer. It's basically for detection purposes.