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Get Your Medical Device CE Marking Faster: Conformity Assessment by Notified Bodies.
The European Union (EU) was once the market of choice to launch new medical device technology. The regulatory system, implemented through a partnership between governments and designated private organizations (notified bodies; NBs), created a flexible and agile route to market that was respected globally.
In 2017, the new EU MDR (Regulation 2017/745; 1) updated the regulations that govern production and distribution of medical devices. It included new requirements and some familiar concepts were changed. The conformity requirements now focus on clinical evidence to support the specific claims made by the manufacturer and all data appraised and analyzed needs to be available to the NBs. In addition, the EU MDR expands regulation from the original pre-market approval across the entire medical device lifecycle.
Technical Documentation (TD) is key to support both you, the manufacturer, and routes to market. Where the devices had CE-marking under the old regime, significant updates to the TD are required to cover the new content and structural requirements for the EU MDR. The greater content was predicted to increase the time - and cost - of NB conformity assessment for applicable devices. However, data released towards the end of 2022 suggested NB review is taking much longer than expected: an average time of 18 months for certification where TD reviews were involved. This same survey indicated a significant number of submissions were incomplete. Indeed, the huge number of questions raised by NBs to manufacturers during the conformity assessment process can more than double the original quoted time for the TD review, raising costs and blocking the route to market for new innovation, as well as threatening disruption to the supply of medical devices across the EU.
This article aims to provide a high-level overview to help manufacturers avoid common mistakes that lead to their NB conformity assessment process to be prolonged.
A brief history of the European regulatory landscape
For many businesses, the implementation of the EU MDR has triggered re-evaluation of processes and regulatory strategy. Whilst there are some Quality Management System (QMS) requirements that should not be overlooked, the main focus is on TD content and structure.
As with all change, it takes time for the new normal to become familiar for all parties concerned. During the early days of implementation of the EU MDR, there was little guidance and few tools to support the process. The regulations also widened the communication gap between NBs and manufacturers.
Manufacturers of certified devices breathing space to get their TD right before submission; and
Manufacturers of novel technologies to finally get an audience with a NB and plan their regulatory strategy.
In order to make the most of this opportunity, let’s consider the conformity assessment process and how it is applied.
Overview of the NB conformity assessment process
When a NB is involved in the conformity assessment process, expect:
A completeness check when you submit your application and TD;
A TD review involving expert input, including technology experts and clinicians;
Questions that require your response;
Questions to be raised to your responses;
A maximum number of question-response rounds before you are required to re-submit;
The output of the TD review to guide the on-site audit;
More questions as a result of the on-site audit; and
Certification when all questions are closed; although there can be some exceptions.
Some NBs provide you with a contact person who will guide you through the process and feedback information at regular points; others ask you to submit the TD and then will become very, very quiet. This silence is enormously frustrating for you the manufacturer as income – funding or sales – often depend on certification dates and without visibility on the timeline, you cannot prepare investors, customers and employees for the next stage. Certainly, a good reason for selecting one NB over another is the customer service. However, loyalty does bring some advantages, as a NB team familiar with your organization, your products and your previous conformity assessments, potentially facilitates the EU MDR transition.
Previous EU conformity assessments can be leveraged to demonstrate meeting some of the EU MDR requirements. The amount of information that can be leveraged depends on:
The device and whether the classification or requirements have been significantly impacted by the implementation of the EU MDR;
The data in the previous conformity assessment meeting the EU MDR requirements; and
The records of previous conformity assessments being sufficiently detailed and complete to allow the NB to perform their due diligence before accepting this evidence.
Importantly, although former CE-marking is a good start, it is no guarantee of a smooth EU MDR process. In the same way, although approvals in other jurisdictions may help, there are also some similar-but-not-quite-the-same definitions and requirements that could cause you to overlook or misunderstand the EU MDR requirements. It is important to keep talking to your NB to make sure that your submission is as close to the mark as possible. If you are placing products on the market in multiple jurisdictions, make sure updates to your QMS and TD for the EU MDR do not cause problems elsewhere. There are now digital QMS and regulatory tools available that can help; some even support medical device development.
Planning for the conformity assessment process
As the CE certificate is critical for market access, you need to work with your NB to make sure that they can deliver to your timelines and the documents you submit make it as easy as possible for them to do their job. Use the resources available, in particular, the requirements of the Regulation and the joint NBs’ interpretations.
There are several other resources that may help provide background and identify common themes across different jurisdictions, allowing your to identify the particular requirements of the EU MDR:
The International Medical Device Regulators Forum (IMDRF) published an internationally harmonized structure for the TD.
Talk to your NB to find out their expectations, including for the format and structure of submissions. Make sure that you fully understand the deliverables: it may be helpful to include someone with experience of EU MDR submissions in the call. It is important to keep in mind the documentation submitted should have full evidence conformity with all applicable requirements.
Make sure that you align your submission planning with change control: the TD review may take several months and changes implemented during this period could lead to complexity and increased costs for re-reviews.
Importance of good record keeping and document control
At all times, you should know which documents and versions you have sent to the NB and when they were sent so that communication can be accurate and focused. Where documents need to be updated during the conformity assessment, make the changes since the last review by the NB clearly identifiable so that the entire document does not need to be re-reviewed.
As the number of rounds of questions is limited - send the right documentation first time.
Keeping on top of communications, including change
Manage the NB’s time by knowing what they expect from you and what you expect from them.
If you do not have a unique contact person in the NB, try to establish one and keep them in copy for all communications. Keep a record of communications in case your team changes.
The EU MDR has many familiar elements, but is an entirely new legislation with very prescriptive requirements. Experience is a huge benefit in preparing TD that will both support the medical device manufacturer and allow smooth approvals in the EU and other jurisdictions. In addition to the traditional roles in TD construction, it may be helpful to use consultants to input experience or walk through the NB conformity assessment process before submission of the TD or responses to the NB questions. This fresh set of eyes will help ensure completeness and conciseness, preventing delay and spiraling costs during the conformity assessment process.
Also, if you haven’t already migrated to a digital QMS, now is the time! Some systems are linking to regulatory requirements to help you identify what documents you need to prepare and what is needed for each stage of your CE marking journey.