In this blog, Domino’s panel of experts will examine the impact of the COVID-19 pandemic on the European Union Medical Device Regulations (EU MDR), originally scheduled to take effect this year. The discussion will delve into the primary challenges currently confronted by medical device manufacturers regarding these regulatory changes. The panel includes Craig Stobie, Director of Global Sector Management; Bart Vansteenkiste, Global Life Sciences Sector Manager; and Volker Watzke, EU Medical Devices Sector Manager. *Please note that this photo was taken before COVID-19.
Recent Revisions to EU Medical Device Regulations
In the past year, several amendments have been made to the EU MDR, and not all are directly related to the impact of the COVID-19 pandemic. One significant change was the two-year postponement, announced in October 2019, of the European Databank for Medical Devices (EUDAMED), the database where manufacturers are required to register new medical devices entering the European market. Originally, manufacturers had an 18-month registration window following the full launch of EUDAMED, scheduled for November 26, 2021. However, with the delay in EUDAMED, this timeline has been adjusted to commence 18 months after the official notice on EUDAMED functionality is published in the Official Journal of the European Union. It’s important to note that in certain cases, such as mandatory registration following a serious incident or field safety corrective action reporting, devices may need to be registered earlier. The delay in EUDAMED can be attributed, in part, to the transfer of responsibility for the EU MDR from the Director General for Internal Market, Industry, Entrepreneurship, and SMEs to the Director General for Health and Food Safety, leading to administrative delays. Technical delays have also occurred as not all modules linking to EUDAMED were finalized as swiftly as initially planned. Additionally, at the onset of the COVID-19 crisis, the compliance date for the EU MDR was pushed back. In March 2020, the European Commission proposed a one-year delay to the regulation due to COVID-19, a decision confirmed in April 2020, resulting in the new compliance deadline of May 26, 2021.
Impact of EU MDR Delay on Medical Device Manufacturers
The initial two-year delay to EUDAMED would not have significantly impacted medical device manufacturers. They still needed to have all the required documents, correct coding, and tracking information for their products by the original compliance date. The delay only affected the registration of devices onto EUDAMED. Until April of this year, manufacturers were working towards the initial compliance date of May 26, 2020, sharing data on new medical devices with national authorities, governments, and health ministries. Pushing the compliance date back to May 26, 2021, provides manufacturers with more time to prepare for the legislation. While some companies may use the extra time to delay their preparations, given the current circumstances, it is likely that most will use the time wisely.
The ongoing COVID-19 situation highlights the significance of having comprehensive information about medical devices entering the European market. Numerous governments lack access to data about the medical devices present in their markets, and they are unaware of the quantities. The challenges seen with face masks and PPE underscore the difficulty of maintaining device stocks when governments lack this visibility. – Volker Watzke, EU Medical Devices Sector Manager
The present circumstances strongly emphasize the significance of the EU MDR regulation, and it appears probable that the revised timelines will remain intact, with no anticipated further delays to the regulation after the conclusion of the COVID-19 pandemic.
Naturally, the outcome hinges on the duration of the ongoing COVID-19 crisis and its impact on European markets. Although it might lead to additional postponements, I believe the one-year delay has been introduced to help manufacturers better navigate the present circumstances, and I do not foresee another extension. – Volker Watzke, EU Medical Devices Sector Manager
Adaptable Manufacturing Amidst the COVID-19 Challenge
In the past few months, there has been a surge in the need for and production of specific medical devices, such as personal protective equipment (PPE), due to the ongoing COVID-19 circumstances. Numerous companies, both in Europe and globally, that were not previously involved in the production of medical devices have now joined the market, focusing on disposable masks and PPE to meet the significant rise in demand.
These manufacturers must ensure that their products, especially PPE, meet the necessary standards and are fit for their intended purpose. It is crucial that they adhere to the correct standards and grading, including appropriate CE marks, and also use non-toxic ink for proper marking. – Craig Stobie, Director of Global Sector Management
Upon the implementation of the EU MDR, face masks will be categorized as Class 1 medical devices, indicating low or moderate risk to patients, and will necessitate coding compliant with EU MDR standards. While existing face masks in Europe may not presently need to comply with EU MDR regulations, they still must undergo coding in accordance with European product safety standards and regulations.
Various manufacturing standards apply to face masks, with distinctions based on the mask type, including surgical masks with N95 ratings and those crafted by individuals at home. Several companies are manufacturing masks that might not presently fall under existing medical device regulations; nevertheless, they will need coding for elements such as a CE mark or batch code, emphasizing the need for compliance. – Bart Vansteenkiste, Global Life Sciences Sector Manager
New entrants venturing into the medical device sector face a multitude of considerations in coding their products. It’s not only crucial to ensure compliance with existing regulations but also imperative to choose a coding method that aligns with the nature of the device being manufactured. Specifically, for face masks and PPE, the selection of an appropriate coding solution should take into account factors such as the overall durability, longevity, and toxicological composition of various ink types.
Selecting the Appropriate Ink for Your Product
In the end, the manufacturer bears the responsibility for any product introduced to the market. Nonetheless, it is crucial for manufacturers to seek guidance from a coding and marking supplier to ascertain the appropriate strategy for coding new items like face masks.
We can assist companies venturing into the production of these items for the first time by providing inks specifically tailored for the sector, ensuring their safety for use on face masks and PPE. These inks adhere to EuPIA standards and are free from any substances that may cause skin irritation. – Volker Watzke, EU Medical Devices Sector Manager
Choosing the appropriate ink is crucial for medical device manufacturers in the present circumstances, whether they are newcomers to the market or not. This is a vital facet of the assistance Domino offers to medical device producers. Amid the COVID-19 crisis, Domino staff globally have been assisting customers and are actively conducting additional tests related to coding and marking on face masks and PPE.
We aim to provide our customers and medical device firms with a comprehensive strategy for identifying the suitable ink for their product. This involves not only concentrating on inks and their appearance on the substrate but also educating substrate providers about the impact of certain consumables, such as inks and ribbons, on their product.
Classification of Medical Devices According to the EU MDR
In December 2019, the European Council published the second corrigendum of the MDR, providing extended compliance timelines for manufacturers producing specific Class I medical devices, as well as Class 2 and 3 medical devices previously categorized as Class 1 under the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).
When examining the majority of Class 1 products, manufacturers must adhere to the regulations and perform the same data collection as manufacturers of Class 2 and Class 3 products. Manufacturers of General Class 1 products are still required to register their devices on EUDAMED, but certification by a Notified Body is not necessary. – Volker Watzke, EU Medical Devices Sector Manager
Navigating the Path to Compliance
To ensure compliance with the EU MDR, manufacturers of Class 1 medical devices should follow a series of steps to streamline the process. The Medical Device Coordination Group published a document in late 2019 titled “Guidance Notes for Manufacturers of Class 1 Medical Devices,” offering a checklist to assist manufacturers in achieving compliance. A summary of the key steps is provided below.
- Verify that the product qualifies as a medical device
- Determine the specific class of the medical device
- Ensure adherence to the general safety and performance requirements outlined in the
- EU MDR Conduct a clinical evaluation and prepare the necessary technical documentation Seek the involvement of a Notified Body, if required Develop instructions for labelling
- Verify compliance with overall manufacturer obligations
- Ensure compliance with the EU Declaration of Conformity and Ethics Confirm the presence of the CE marking on the product and ensure compliance
- Register the devices on EUDAMED and share information with national authorities Collect and assess post-market data and share it with the vigilance system
Locating a Notified Body
With the original deadline for EU MDR compliance having passed, it may be surprising to learn that manufacturers are still grappling with a scarcity of certified Notified Bodies available to assist in registering their products and obtaining compliance certificates. In the era of the previous Medical Devices Directive, there were 57 Notified Bodies, both within Europe and internationally, aiding medical device manufacturers in bringing their products to the market. However, under the new EU MDR, all Notified Bodies seeking to operate are mandated to undergo audits and obtain designations anew. Currently, most of them are still in the process of being audited and have not yet received designation from EU authorities. As of the current moment, only 15 Notified Bodies have achieved full designation under the EU MDR.
This poses a challenge for manufacturers of medical devices as they currently lack clarity on whom to approach. Certifications obtained from Notified Bodies that are not yet accredited will not be recognized by EU authorities. – Volker Watzke, EU Medical Devices Sector Manager
Out of the 57 Notified Bodies accredited under the previous regulations, around 40 have sought designation under the EU MDR. This indicates that a considerable number of Notified Bodies have opted not to continue assisting medical device manufacturers under the new directive.
As a consequence, certain manufacturers might need to switch to a different Notified Body, possibly disrupting longstanding relationships and potentially facing challenges in finding a suitable Notified Body within their country. There is a shared interest in expediting this process to ensure that Notified Bodies undergo audits and receive designations as swiftly as possible. – Volker Watzke, EU Medical Devices Sector Manager
Nevertheless, due to the ongoing COVID-19 crisis, the assessment of new Notified Bodies has been temporarily suspended, indicating that this challenge is expected to persist for manufacturers in the foreseeable future. The European Commission website provides an updated list of all designated Notified Bodies.
We have extensively discussed the EU MDR in the blog thus far; let’s now shift our focus to other regions to explore if comparable trends are evident beyond Europe.
I believe it’s not advisable for manufacturers to initiate operations in various regions. The most advantageous global markets for commercialization are the US and the EU, both of which are already regulated. Venturing into different global regions would necessitate concentrating on one of the countries within the G20 that is already engaged in regulatory discussions. – Volker Watzke, EU Medical Devices Sector Manager
For newcomers in the medical device manufacturing industry, achieving compliance with the EU MDR might appear to involve significant effort. However, it’s improbable that this alone would hinder innovation within the EU, and startup companies are unlikely to opt for regions outside the EU for the initial commercialization of their products.
Anticipating the rest of 2020, I do not foresee significant alterations for manufacturers based in the UK. Going forward, they are likely to be managed in a manner similar to other manufacturers located outside the EU.
Currently, companies situated in non-EU countries, such as Switzerland and the US, that are required to adhere to the EU MDR, must appoint an EC Rep—an authorized representative under the EU MDR. This representative serves as a legal liaison between non-European medical device manufacturers and EU authorities, Notified Bodies, and EUDAMED.
The Expenses Associated with Adhering to Regulations
Adhering to regulations is not just a logistical challenge; it can also incur significant expenses. In a previous blog, we explored the overall financial implications of complying with the EU Falsified Medicines Directive (EuFMD), encompassing the adjustments needed for item-level serialisation in production environments. The total compliance cost ranged from €100K for smaller manufacturers to €250K for mid to large-sized companies—a substantial financial commitment. Can a similar cost be anticipated for compliance with the EU MDR?
I believe the expenses for compliance with the EU MDR are more manageable compared to the EU FMD, primarily because serialisation will be required in very few instances. It presents a distinct scenario and a different cost perspective. I estimate that achieving compliance with the EU MDR could be ten times less costly than achieving compliance with the EuFMD. – Bart Vansteenkiste, Global Life Sciences Sector Manager.