When preparing any medical device for the European market, manufacturers must produce detailed and accurate technical documentation that clearly evidences compliance with the MDR. Obtaining a CE certificate or issuing a declaration of conformity (DoC) requires proving compliance with the incoming EU MDR 2017/745. Manufacturers can still reach the market by meeting the current Medical Devices Directive (MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. Nevertheless, it’s good practice to prepare for the newer regulations.
A strong structure in your technical files allows regulatory bodies to clearly understand its contents and can help you maintain traceability from the initial device description to latter sections on post-market surveillance. Traceability is necessary to highlight any risks that may be associated with the device as well as other performance and safety requirements.
Examples of relevant documents include a device description and specification section in which you reference a basic Unique Device Identification-Device Identifier (UDI-DI). As well as device description, details of labelling and instructions for use (IFU) are essential and will need to be translated to include the local language of the EU country to which you are applying.
A detailed and well-structured portfolio will also detail information about design and manufacturing, risk management and compliance with General Safety and Performance Requirements (GSPR). Finally, Annex III of the MDR requires you to report any device-related adverse events or problems with the product in the form of post-market surveillance.
While some medical device manufacturers may have in-house regulatory capabilities, not every company is so lucky. If your company lacks these skills, one solution is to consult with external experts for specific projects. For instance, if you are selling a batch of endoscopes or scalpels on the European market for the first time, a freelance EU MDR consultant could compile all the necessary information about the product and structure it in a coherent file ready for the notified body.
In the initial stages of development, you should compile technical documentation detailing the design and manufacturing of your device. This includes specifying the manufacturing processes, any suppliers that were involved and the materials used. Although selling into Europe doesn’t require submitting a design history file (DHF) as is the case in the United States, you will need to specify the design and manufacturing process as part of your quality management system (QMS). The QMS will vary depending on the class of the device, however the notified body will always examine the design to ensure safety and compliance.
Robust design reviews will detail different stages of product design as well as any specific features. Moreover, you must document the design requirements and specifications, and map these to signpost the device’s intended use. Because design and manufacturing information is essential, it is important to cover every angle and leave no stone unturned. External experts can also be sourced to compile these earlier sections of your technical file to ensure that you get off to a good start.
Clinical Evaluation Reports
While the MDD and AIMDD both required clinical evaluation reports (CERs), the incoming MDR places a greater emphasis on them. CERs provide a comprehensive overview of the device’s design and composition, as well its intended applications and any relevant literature reviews. Most importantly, the CER analyses data from clinical investigations carried out on the device to demonstrate that it doesn’t pose a risk to the intended user.
The CER will form a key part of the technical file and, as a living document, you must ensure that it is well prepared and regularly updated throughout the product lifecycle. A detailed CER will contain the clinical evidence that proves that the device conforms to the Essential Requirements (ERs) in MEDDEV 2.7/1 Rev. 4 Annex 1 (Safety and Performance Requirements in the MDR). Even if you don’t have the in-house skills to maintain these reports, external experts can help ensure that your CER strategy is robust and stands up to scrutiny.
One of the common challenges when preparing documentation is missing out vital information that proves conformity. Submission of incorrect documentation could significantly delay the approval process and lengthen the time it takes to get your product to market. One way around this issue is to carry out a gap assessment (GA) to establish any technical documents or regulatory requirements you may be missing.
As well as deficiencies, a detailed GA will highlight ways to fix any issues with the technical file and minimize the chance of your application being rejected. For example, it may flag the need to specify additional labeling information for the local market or clearly signpost how the device complies with ISO 14971 standards on risk management to satisfy the notified body.
Carrying out a thorough GA can be a challenge without the knowledge of what the European Medicines Agency (EMA) and other regulatory bodies may require. Leaving the gap assessment to the last minute also means retrospectively compiling the various documents needed to show compliance with relevant ISOs, which could significantly delay your application. Finally, the process must be impartial to fully account for any faults in the device—therefore it is better to have a third party conduct your GA. If you hire a freelance EU MDR consultant, they will have the necessary knowledge of the EMA and can evaluate your device against the clinical evaluation standards of your device’s class without bias.