1. Define the (new) classification of your MD
The new Medical Device Regulation (MDR) has had several implications for the industry. To begin with, the scope of the regulation has been expanded compared to the previous directives. The MDR now covers non-medical devices, such as colored lenses, for example.
In addition, the number of classification rules has increased significantly. This means that a device can change its risk class. For example, a MD that was previously in class I can now be moved to class IIb.
Determining the risk class of your MD is an essential step in your compliance: the class will often determine your obligations. For example, CE marking for a class I MD can be done through self-certification, while a MD of class IIa or higher will have to be certified by a notified body (NB)..
2. Compile technical documentation
Technical documentation is a key element for medical devices. The technical file will be assessed by the Notified Body (NB) before certification with the medical CE mark.
The technical file is made up of information on the MD concerning its entire life cycle. In particular, it identifies the manufacturer and its representative, the MD and its UDI (Unique Device Identifier), it also contains the design data, the manufacturing file, the package insert, the tests, the clinical validation elements, the benefit-risk analysis, the post-marketing follow-up, etc.
The technical documentation and any proof of conformity must be kept by the authorised representative (if the manufacturer is outside the EU) or by the manufacturer based in Europe in order to present them in case of control by the authorities.
The regulation requires the manufacturer to have a person responsible for compliance. in-house. If the company is too small or this is too complex to apply internally, the regulation recommends using an external service provider. EcoMundo can fulfill this role for you!
A new element of the MDR is the obligation to affix the UDI to the device (within certain deadlines): this identifier concerns all MDs except custom-made devices and will allow the traceability of MDs, regardless of their place of manufacture or use. As the code is international and unique, it allows each MD to be followed throughout its life cycle.
These identifiers will also allow registration of medical devices in the EUDAMED database. This European database centralizes information on medical devices, their post-marketing follow-up, manufacturers, clinical evaluations, etc. on a single portal.
The new regulation now directly excludes non-conformities. To do this, the manufacturer has 3 rounds of questions and answers with the NB, after his complete review of the file. At the end of these rounds, the application will be accepted or refused by the assessor.
3. Choosing the right notified body
Notified Bodies, or NBs, are independent bodies that are subject to very specific rules regarding their accreditation and operation. They are designated by the competent national authorities of the Member States. In France, for example, the ANSM (Agence nationale de sécurité du médicament et des produits de santé) is responsible for authorizing, monitoring and renewing NBs, jointly with the European Commission and two other European competent authorities (this is called joint assessment).
The Notified Body issues the medical CE marking for a period of 1 to 5 years. The choice of NB can be informed by several elements: a previous collaboration of a particular NB with your company or the provider in charge of your compliance, a specialization in a certain type of MD, a preferred market, etc.
The NB checks annually that the requirements are met by the manufacturer. It also carries out a more thorough check when the certificate is renewed.
4. Implementation of post-marketing follow-up
One of the important developments of the new MDR is the monitoring of the benefit/risk ratio of the device throughout the life cycle. The objectives of this monitoring are planned from the design of the MD. These will include confirming the safety and performance of the device, confirming benefit/risk estimates, obtaining new clinical data, and considering the status of technical capabilities.
If you wish to be accompanied in the compliance of your devices, do not hesitate to inquire about our services or to contact our experts!
Wish to know more about medical devices?
For more information, do not hesitate to contact Raïssa Abdel Kader or one of our experts!
