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The Class I medical device manufacturers are now focusing on transitioning from European Medical Device Directives (MDD) to Medical Devices Regulation (EU MDR) 2017/745. For the CE certificates issued under MDD before the implementation of MDR to remain valid until May 2024, this is applicable only under certain conditions. The devices that are under Class I are required to be compliant with MDR.
Well, it indeed stirs a potential dilemma among manufacturers regarding information and documents to be submitted and additional steps to be taken. Keeping a note of a few crucial aspects will help avoid any repercussions. Let us discuss a few brief indicators which are crucial yet can often be missed out in the process.
Do’s!
Understand the New Regulations
With new rules and regulations, new requirements have been added for the self-certification of class I devices. Hence, being aware of and understanding the new regulations is necessary.
Check the Product Scope and Classification
There are 22 rules of classification under the new regulation. It is necessary for the Class I device manufacturers be well informed of the classification rules and check for their devices in case of any re-classification. Unless the manufacturer’s Regulatory staff is highly experienced in EU legislation and CE marking, it is recommended to hire an external Regulatory consultant to confirm classification and whether the device classifies for self-certification or not.
Keep a Check if the Involvement of Notified Body is Required
Non-sterile and non-measuring devices do not need to go under any conformity assessment. These general Class I devices can be self-certified directly. However, other Class I category devices require the involvement of the Notified Body, and it is limited in the case of:
- Sterile Devices: Conformity of devices concerning secured sterile conditions
- Measuring Devices: Conformity of devices concerning metrological conditions
- Reusable Surgical Instruments: The conformity of devices concerning the re-usability of devices (disinfection, sterilization, etc.)
Keep all the Documents Ready
All Class I device manufacturers, irrespective of the sub-category, must update their technical documentation as per the new regulations. All the requirements of technical documentation are covered in Annex II and III. The technical documentation should include device description, specification, variation and accessories, information to be supplied by the manufacturer, general safety and performance requirements, etc. The CE-marked product should also be registered in EUDAMED. Upon request, manufacturers must produce the technical documents to the competent authority.
Know Your Routes
Even though all the Class I device manufacturers can self-certify, the assessment route and regulations applicable change as per the sub-category. For instance, in the case of sterile and measurable devices, the manufacturers also need to follow Annex IV, V, and VI. Hence, understanding the product's classification and knowing the regulations applicable is quite pivotal.
Don’ts!
Sticking to Old Approaches
The need for modifying the working technique occurs as regulations are constantly revised, and new needs are implemented. It is critical to stay on top of new criteria and respond appropriately during the transition time to place products on the market.
Act Slowly!
Manufacturers with devices that have the declaration of conformity drawn before May 26, 2021, and requiring conformity assessment as per the MDR can place their devices in the market up till May 26, 2024. However, with the limited Notified Bodies, the manufacturers might compete for their services. Thus, one should act rapidly and not miss out on complying with the new regulations.
Forget to Register Your Device and the Company
Upon receiving the CE mark, manufacturers are required to obtain UDI and list their devices in the EUDAMED system. In addition, manufacturers are also required to undergo Actor Module Registration, registering themselves and their EAR (if applicable) in the EUDAMED system.
Don't Hesitate to Take Expertise Support
Obtaining a thorough understanding of the new regulations and standards for Class I devices might be complex, leaving the manufacturers in ambiguity. Hence, manufacturers must be equipped with rich experience in EU legislation. Regulatory expertise plays a crucial role, and experienced professionals can provide a tailored and legitimate approach to the new transitions.
It is quite important for manufacturers to understand the new regulations and take the necessary steps accordingly within time. Failure or delay in complying with the regulations can affect the device's market approval. So, we advise you to adhere to the new requirements and take the subsequent actions appropriately.
Do you require support in complying with the new regulations? We will be happy to assist you!
