Newsletter No 16 July 2020
MDR annexes – An underestimated part (Part 2: Important annexes)
In summery the MDR contains seventeen annexes. Some of them have been mentioned in previous newsletters of STS Medical Group, therefore this newsletter will concentrate on the annexes, which contain essential information. The June newsletter has introduced all annexes to you in short, but the requirements of the MDR need a closer look into the different topics. Let’s dive deep into some chosen annexes. Below the annexes are according to their relevance when placing a product on the market.
Relevant annexes of the MDR
Classification rules for medical devices are essential for the MDR. Without the clear classification neither the essential requirements nor the technical documentation including the post market surveillance are possible. The classification influences the type of technical files, the efforts for development, the clinical assessment, the timeframe for post market surveillance actions, just to name a few topics. Compared to the MDD the MDR has changed in some parts. The classification is getting much closer to the essential requirements and the technical files. For some product a reclassification could be necessary. Be prepared that a reclassification will cause a lot of other changes in documentation, production and monitoring.
Due to the impact of the classification and the possible change of the risk class this annex has become very important for the MDR. So what are the changes between MDD and MDR? On the first glance there are four additional rules (22 instead of 18). The first differences can be seen in the definition chapter. The duration of use remains the same, but the definition of “invasive” differs from the MDD. There is no general definition of invasive anymore and implantable devices in general are not defined in the MDR neither. Due to the high increase of requirements for implantable materials, this definition has been lost by mistake. Also lost is the general definition of an active medical device which seems a major decision. As you know, an active device is very different from a non-active device, so a completly different documentation will be needed. Clause 2.8 adding injured skin or mucous membrane is new. A better explanation of the term “continuous use” seems useful to avoid misunderstandings. The rules itself may differ in some details.
|Rule||Changes relating to MDD|
|2||Additional mentioning of blood bags instead of MDD rule 18|
|3||Additional mentioning of in-vitro-use|
|5||Defining the classes of active medical devices|
|8||Additional mentioning and definition of implantable devices|
|9||Additional mentioning of devices intended to emit ionizing radiation and active devices that are directly influencing the performance of active implantable devices|
|11||This rule is new and defines the importance of software used in medical devices or as a standalone system|
|12||This rule (rule 11 in MDD) contains no changes|
|13||This rule (rule 12 in MDD) contains no changes|
|14||This rule (rule 13 in MDD) contains only changes in wording|
|15||This rule (rule 14 in MDD) contains no changes|
|16||This rule (rule 15 in MDD) contains no changes|
|17||This rule (rule 16 in MDD) contains no changes|
|18||This rule (rule 17 in MDD) includes tissues or cells of human or animal origin|
|19||This is a new rule and defines the classification of products which contain nanomaterials|
|20||This new rule adds administering of medicinal products by inhalation|
|21||This new rule adds devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin|
|22||This new rule introduce active therapeutic devices with an integrated or incorporated diagnostic function to the classification process|
Annex IX: Conformity assessment based on a quality management system and assessment of the technical documentation
Annex X: Conformity assessment based on type examination
Annex XI: Conformity assessment based on product conformity verification XII Certificates issued by a notified body.
The annexes IX, X and XI contain the same requirements. The first one is an established and maintained quality management system according to ISO 13485 or ISO 9001 standard. The MDR refers to these standards without mentioning them in detail. The selection of the used standards depends on the classification of the products. For a product with risk class I standard ISO 9001 may be sufficient but for a product with a higher risk class like IIa standard ISO 13485 is mandatory. For this reason, every year the Notified Body needs to assess the functionality of the quality management system. These audits are called “monitoring or vigilance audits” and may differ from the recertification audits every three years.
The second requirement is the technical documentation which also depends on the risk class of the product. It is obvious that the classification of the medical devices has a very big influence on all following documents. To fulfill this requirement there is a need for technical documentation according to annex II and/or annex III.
To place a product on the market, a conformity assessment is mandatory and has to be proved. Some of the components for the evidence may sound familiar to you, as there are risk management, usability, post market surveillance or technical specifications. The process of a conformity assessment means that the Notified Body has to assess and sometimes even to test the medical device including the technical files. The assessment will relate to function, referring documents like risk management, usability, post market surveillance, instruction for use, clinical data, and system performance just to name a few.
A first overview of equal/identical products from competitors is always part of the introduction and the assessment process. This assessment covers the introduction of new products to the market as well as changes made to the product in design or function. If the intended purpose changes or be limited, a new assessment is also required by the Notified Body. When the product is already placed on the market, all involved processes should guarantee a maximum of possible quality during the production.
Annex XI allows two different ways to proceed:
a.) The production quality assurance way needs a working quality management system according to annex IX. Such a management system is provided by the company and assessed by the Notified Body. This quality management system has to cover all processes, which are related to the product like development, incoming control, production, final testing and so on. It is important to understand that all technical files and all production documents are part of the maintained quality system and will be assessed by the Notified Body. Especially for class IIa and higher classified products, an annual assessment of a working quality management system also contains the review of a selected technical file. This way is common for products, which are placed on the market in a non-sterile condition and for products which are not meant to be sterilized during their lifetime.
b.) The product verification way becomes important if the products will be provided sterile to the market or are designed for sterilization by the customer. The core process of the production is the sterilization step that has to be monitored. To use sterilization as an example, a company needs to monitor two steps of the process. The first step is the sterilization process itself. The process has to meet the regular requirements and has to give proper results (sterile products). The process verification has to be done at least once a year, including the check of process parameters, residuals left and effectiveness.
Without the process verification, the sterilization process is not monitored and can pose a risk to patients. The second step is to monitor each single batch that is being sterilized. In the beginning, this will contain the usability of raw materials for sterilization, suitable packing material and the approval that product and sterilization process will fit together. This may sound easy but keep in mind, if you have a product which contains long thin tubes or extensions, the sterilization method needs to cover this and will be more complicated than for a massive plier.
The batch monitoring could be done by sampling some products of the batch or by indicators that change their color as soon as sterilization process was successful. The monitoring contains also the establishing of a post market surveillance system according to annex III and the assessment of clinical data according to annex XIV.
To assess all these different information a working quality management system is required. Product related documentation of all verification steps has to be done in the technical files.
These are the reasons why the MDR insists on a working quality management system and the maintained technical files according to the annexes.
As you see, the annexes of the MDR are closely related to a quality management system and the technical files. This relationship defines the essential requirements needed to a working quality system, a safe production and a proper documentation of all steps done. This may include changes in the process, material changes or replacing, updating and revision of processes and so on. STS Medical Group takes the annex requirements of the MDR very seriously and follows the requirements if applicable. This has been achieved by a full transparency policy and a successful cooperation with National Authorities and Notified Body.
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 September after summer break.
You want to know more about specific topics? Do you have any questions or comments? Write us!
CEO STS Medical Group
Dr. Sönke Asmussen
Group Manager for Quality System Compliance