The question of how long it will take to obtain CE marking is one of the first, if not the very first, inquiries that companies have. Unfortunately, providing a definitive answer to this question is exceedingly challenging due to the multitude of factors at play.
The CE marking process is intricate and multifaceted, encompassing various stages such as conformity assessment, documentation preparation, and engagement with Notified Bodies. The duration of each stage can vary significantly based on factors like the device classification, complexity, and the thoroughness of documentation. Moreover, the availability and workload of Notified Bodies, who assess device conformity, can also impact timelines.
Despite the complexity and variability inherent in the CE marking process, we can attempt to outline average timelines based on industry experiences. By breaking down the process into its constituent parts and considering potential bottlenecks or delays, we aim to provide medical device companies with a clearer understanding of what to expect on their way to obtaining CE marking.
Manufacturer and Notified Body timelines
Basically, the CE marking process can be divided into two main categories of steps, each with its own set of dependencies and timelines. These categories encompass steps primarily influenced by the manufacturer and those predominantly influenced by the Notified Body responsible for assessing device conformity.
Hence, the timelines for various steps in the process can be attributed to two primary influencers: the medical device company itself and the availability of the Notified Body responsible for regulatory assessments.
While medical device companies have control over the timelines for internal steps within the CE marking process, Notified Bodies influence the timelines for NB-dependent steps. Active collaboration with the Notified Body, proactive communication, and strategic planning can help navigate potential delays and optimize overall timelines for achieving CE marking and market access for medical devices.
Steps primarily influenced by the manufacturer
The steps that largely depend on the manufacturer include activities such as developing technical documentation, conducting risk assessments, and implementing quality management systems. Manufacturers have control over these aspects and must ensure that they are executed timely. The timelines for these steps are defined by the medical device company itself, reflecting their commitment to thoroughness, accuracy, and regulatory compliance.
Firstly, manufacturers must ensure that their medical device complies with the relevant European Union (EU) regulations, the Medical Device Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR).
This involves conducting an assessment of the product's technical documentation and the manufacturer's quality system. If something is missing or needs to get rectified, this should be done beforehand.
Once the necessary documentation is prepared, manufacturers must select a Notified Body to assess the conformity of their device.
Besides, you should consider the time required for essential tasks such as identifying an authorized representative (if your company is based outside of the EU), securing a Person Responsible for Regulatory Compliance (PRRC), obtaining a Basic UDI (Unique Device Identifier), and completing EUDAMED registration when calculating your timeline.
The timlene for these activities depends on the medical device company itself. It is you who defines the timelines for these activities and keeps up with them. Basically, if an average company invests in these activities enough effort and resources, they can manage it within 2-4 months.
Steps primarily influenced by the Notified Body
On the other hand, there are steps in the CE marking process that predominantly hinge on the Notified Body's involvement. These steps typically include the assessment of technical documentation, conducting audits and inspections, and issuing certificates. The timelines for these steps are influenced by factors such as the availability of the Notified Body, their workload, and the complexity of the device under evaluation. Manufacturers must be mindful of these external factors, which may affect the overall duration of the certification process.
The Notified Body will review the technical documentation, and the quality system. After that it will conduct on-site inspection if necessary (in vast majority of cases, it is). Upon completion of the conformity assessment, if the device meets the regulatory requirements, NB will issue the certificate.
As said above, the timeline for Notified Body assessment can vary depending on factors such as the availability of the Notified Body, the complexity of the device, and the completeness of the documentation. Typically, the assessment process may take several months, although it can be longer for high-risk devices requiring more extensive review.
As a general principle, if technical documentation is adequately prepared, the process will be expedited. Conversely, if there are numerous deficiencies, the audit may necessitate multiple rounds, prolonging the time required for addressing and rectifying these deficiencies.
At a broad planning level, it is advisable to anticipate a timeframe of 6 to 14 months for the Notified Body to complete the certification process.
Timelines for class I medical devices
Class I medical devices, with the exception of sterile and measuring devices, as well as single-use surgical instruments, do not necessitate Notified Body certification. Consequently, for Class I products, steps dependent on a Notified Body are not applicable. Therefore, the timeline for Class I devices is entirely contingent on the medical device company and its dedication to CE marking projects.
If your documentation for a Class I device, along with the quality system, already aligns with the requirements of the MDR or IVDR, you will only need to complete minor tasks such as appointing an authorized representative, identifying a Person Responsible for Regulatory Compliance (PRRC), obtaining a Unique Device Identifier (UDI), and registering with EUDAMED. Once these tasks are accomplished, you can proceed to place your Class I device on the EU market.
Summing up...
While there is no fixed timeframe for obtaining a CE mark for a medical device, manufacturers should plan for a thorough process that may take many months to complete. Collaboration with regulatory experts can help streamline the process and ensure timely market access for the device.
