Preparing for the EU Medical Device Regulation
The EU Parliament has adopted the EU Commission’s proposal to postpone enforcement of the EU Medical Devices Regulation (MDR) by one year until May 2021. The decision to delay was made in response to the COVID-19 outbreak’s impact on manufacturers, notified bodies, suppliers, research institutions, and other parties, with patient health and safety as a guiding principle. Though this delay would give businesses an extra year, it will be challenging for some businesses to prepare in the context of the pandemic. (The proposal does need to be approved by EU member states and published in the Official Journal before it will enter into force, but this is expected by May 26, the EU Parliament reports.)
The shift from the previous regulations, the Medical Devices Directive (MDD), to the MDR (officially titled Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices), will bring significant changes and a more stringent requirement to obtain the much-needed CE mark. The impact will be felt by every medical device manufacturer in the EU―and those that sell into the EU―because it will apply to existing products, not just new entries to the market.
Kolabtree has had many enquiries from medical device manufacturers who need help from a freelance scientist, whether it’s with adjusting to changes to traceability, device classification, or post-market surveillance. Commonly though, we find businesses are looking for a medical writer to help with their technical documentation, which we’ll come on to later. Some common enquiries relating to the changing regulations are explained below.
Under both the MDR and the MDD, medical devices are categorized into four classes: I, IIa, IIb, and III, with the classification relating to the degree of risk associated with a device. The new regulations mean that some products will fall into a different group than they did before.
“The fact that certain products will be moved into a different class is likely to cause difficulties, particularly if a product will be moved to a higher class,” explains Kolabtree freelancer Dr. Sergio Perez. “The change of class will affect other areas of the regulation and, if the device is moved into a higher class, will come with more stringent requirements.
“For example, the manufacturer may need to provide additional data on an existing medical device if a device moves from Class IIa to III, where a clinical investigation is needed to justify certain clinical claims,” he adds.
Another cause for concern may be for companies whose products were not previously classified as medical devices at all. Liposuction equipment and contact lens solution, for example, will be covered under the MDR, so manufacturers of such products will need to catch up quickly with MDR requirements.
Under the MDR, you can meet the safety and performance requirements using either clinical data from your own device or an equivalent device. The purpose of claiming equivalence is to avoid having to conduct redundant studies. One reason this may be challenging is that the MDD did not define equivalence, while the MDR has a clear statement on what it is.
Under the MDR, it will be more difficult than it used to be to claim equivalence. According to the definition, you must prove that a product is biologically, technically, and clinically equivalent to the reference product, and it may be difficult to come across this degree of information on a competitor’s product.
If a company is no longer able to claim equivalence with a product that they previously could under the MDD, they may be required to perform further research or remove a claim from their product.
Many manufacturers of devices that have been on the market for years will have to determine whether they have enough clinical data to comply with the MDR. This will prompt them to take steps such as conducting their own post-market clinical follow up studies and other post-market surveillance activities.
Clinical Evaluation Reports (CERs)
A clinical evaluation report (CER) is part of the technical file that provides information on the device design, features, intended use, risks, data sources, and more. Producing CERs involves multiple stages: defining the scope of the device, collecting and validating clinical data, analyzing and interpreting the data, competitor and equivalence analysis, and identifying risks and uncertainties during post-market surveillance. This is an ongoing process, which should be updated throughout a device’s lifecycle.
The MDR will increase the emphasis on CERs, requiring an increased level of knowledge, understanding, and expertise. This stepped-up level of understanding combined with the significant amount of changes from the previous regulations will make CERs into a stumbling block for companies transitioning to the new regulations.
“Identifying and gathering all the data that goes into the CER and preparing the document according to the guidelines can take several weeks or months,” explained Kolabtree freelancer Dr. Sophie Laurenson. “Post-market surveillance (PMS) forms a big part of the process even after CE Mark certification, and PMS has to be a core part of the manufacturer’s quality management system (QMS). Some cases also require post-market clinical follow up (PMCF) which involves proactive collection of clinical data and evaluation to meet safety and performance requirements.
“The CER is not a static document. It is recommended that medical device manufacturers develop a robust process and strategy incorporating good practices to help them retain market access in the EU, avoid any product recalls and streamline their time and resources used to maintain the document,” she added.
Because of such challenges, numerous companies are hiring a freelance clinical evaluation report writer. When looking for a CER writer, it is important to look for a qualified expert with experience in clinical research methodology across a range of therapeutic areas. They should also be experienced in regulatory affairs and well versed in scientific literature, added Kolabtree freelancer Mahasweta Pal.
Adapting to all the changes in the MDR can seem overwhelming for many medical device manufacturers. While the original deadline has been extended by a year, manufacturers still need to prepare themselves so that they can obtain that much-needed CE mark in time for May 2021.