Newsletter No 15 June 2020
MDR annexes – An underestimated part (Part 1: General overview)
Since the new medical device regulation was officially approved by the European Commission and the companies started walking the journey to become MDR compliant, medical device producers had to increase their focusing on the given users rationales (1 – 101).
While working with the rationales described in the wording of the regulation here is a significant danger to underestimate the content of information and requirements based on the annexes of the MDR.
This newsletter will give you an overview of the annexes and their relevance for medical devices of class I and IIa.
Annexes of the MDR
In summary the MDR contains seventeen annexes. Some of the annexes have been mentioned in our previous newsletters, so in this newsletter we will concentrate on the annexes which have not yet been mentioned. In detail the annexes are:
I General safety and performance requirements
II Technical documentation
III Technical documentation on post-market surveillance
IV EU declaration of conformity
V CE marking of conformity
VI Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system
VII Requirements to be met by notified bodies
VIII Classification rules
IX Conformity assessment based on a quality management system and assessment of the technical documentation
X Conformity assessment based on type examination
XI Conformity assessment based on product conformity verification XII Certificates issued by a notified body
XII Certificates issued by a notified body
XIII Procedure for custom-made devices
XIV Clinical evaluation and post-market clinical follow-up
XV Clinical investigations
XVI List of groups of products without an intended medical purpose referred to in Article 1(2)
XVII Correlation table
Closer look into the annexes
Let us take a closer look into the annexes and introduce them to you. A more in-depth reflection of important annexes will be done in the July newsletter.
Annex I: General safety and performance requirements has been the main topic of newsletter 03/2020. This annex gives the basic information about what makes a product become a medical device.
Annex II: Technical documentation contains the basic requirements of what is needed to establish and maintain the technical files. This topic became so extended and so important that it will might be dealt with in a future newsletter. The requirements for technical files will include labeling inclusive UDI, the risk management, the check for usability, the post market surveillance and results including all the steps done to minimize the product risk.
Annex III: Technical documentation on post-market surveillance was partial mentioned in newsletter 05/2019
Annex IV: EU declaration of conformity contains not only the common requirements like product name, supplier address, batch or serial number if helpful, responsibilities and classification, information about the Notifies Body, but also additional basic UDI, intended use and specification to identify the product. The answer if a declaration of conformity does expire or need an expiry date as requested by a lot of Notified Body´s is still missing.
Annex V: CE marking of conformity show how the CE mark should look like. This is nothing new and was taken from the MDD.
Annex VI: Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29; and the UDI system was partial mentioned in newsletter 06/2019. The UDI topic will be individually discussed in a future newsletter.
Annex VII: Requirements to be met by notified bodies could be helpful if a company would like to change their Notified Body and would need some guidelines during the transition period. But this annex is mainly directed to controlling authorities.
Annex VIII: Classification rules for medical devices has changed in some parts. Due to the impact of the classification and the possible change of the risk class this annex has become very important for the MDR. The classification is close connected to the essential requirements and the technical files.
Annex IX: Conformity assessment based on a quality management system and assessment of the technical documentation involves not only the standard ISO 13485 or ISO 9001, but also the need for a technical documentation according to annex II. The basic requirement, that a company who producing or trading with medical devices need a working quality system. This was check by the Notified Body during the vigilance audits.
Annex X: Conformity assessment based on type examination means that the Notified Body tests a chosen medical device including the technical files. The assessment will relate to function, referring documents like instruction for use, clinical data, and system performance just to name a few. This assessment covers the introduction of a new product to the market but covers also changes made to the product in design or function. If the intended purpose changes or will be limited a new assessment is required by the Notified Body.
Annex XI: Conformity assessment based on product conformity verification XII Certificates issued by a notified body. This annex is very close connected to the basic requirements mentioned in this newsletter, as working with a quality system (Annex IX), a technical documentation according to annex II and/or annex III. Annex XI allows two different way to proceed:
a.) PRODUCTION QUALITY ASSURANCE which means that for production a working quality system according to annex IX is required and will be provided by the company. Especially for class IIa products this contains an annual assessment of a selected technical file.
b.) PRODUCT VERIFICATION is important if the products will be provided sterile to the market or are designed for sterilization at the customer. This contains also the establishing of a post market surveillance system according to annex III and the assessment of clinical data according to annex XIV.
Annex XII: Certificates issued by a Notified Body should contain the requirements given in this annex. The Notified Body know themselves best how these certificates should look like.
Annex XIII Procedure for custom-made devices will include products like glasses or braces and customized prosthesis. This may also refer to products which are made in a very small quantity like one or two pieces. These products are made for treating one single customer/patient. Products which are used by more than one known patient/user are not affected by this annex.
Annex XIV: Clinical evaluation and post-market clinical follow-up was mentioned in our newsletter 07/2019, we invite you to refer to that newsletter.
Annex XV: Clinical investigations during the development process are a very complex topic. However, this is not STS main segment, in this newsletter we will briefly mention the annex, but we will not provide in depth details about it. We advise you to refer to your clinical expert for more information.
Annex XVI: List of groups of products without an intended medical purpose referred to in Article 1(2) is new and defines these types of products. There is a close connection to cosmetic surgery.
Annex XVII: Correlation table shows the relationship between MDR and MDD this could be used for a gap analysis or just as a shortcut to find the relevant chapter from the MDD in the MDR.
As you see, the annexes of the MDR are closely related to each other. This relationship defines the essential requirements needed for an operative 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 group takes the annex requirements of the MDR very serious and follows the requirements if applicable. This was achieved via 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 July.
You want to know more about specific topics? Do you have any questions or comments? Write us!
CEO STS Medical Group
Corporate Director Quality Management
and Regulatory Affairs