The EU Medical Device Regulation: What’s Next?

McDermott Will & Emery

McDermott Will & Emery


The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance for medical devices within the European Union, and have far-reaching consequences for the life sciences industry.


The new EU Medical Device Regulation (MDR) (2017/745) will enter into application on 26 May 2020. It was published on 5 May 2017, following a years-long revision process. Published the same day as the MDR, the In Vitro Diagnostic Medical Device Regulation (IVDR) (2017/746) is set to enter into application on 26 May 2022.

The Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), which constituted the previous regulatory framework for medical devices in the European Union, are repealed with effect from 26 May 2020, with a few exceptions.

The new Regulations bring about a long-awaited change in legislation. Medical devices represent a key industry in the European Union: more than 500,000 medical devices are currently in circulation in Europe, encompassing a broad range of products and generating about EUR 100 billion in annual sales. The previous Directives have been in place for more than 25 years and have proven insufficient to address the considerable technological transformation of the medical device industry. The 2012 PIP implant scandal further highlighted the need for market vigilance and transparency, including public access to information.

The MDR has far-reaching consequences for the industry. It sets out new and far more stringent requirements for medical devices, which will affect clinical evaluation, conformity assessment procedures, traceability and market surveillance, among other obligations. Considering the significance of these changes and the operational issues they raise, there is widespread concern in the industry that many actors will be unable to fully comply with the MDR by the general date of application. This could negatively affect the availability and safety of medical devices in the European Union.

Broader Scope, Stricter Requirements for Medical Devices

The MDR expands the scope of the regulation to include previously unregulated products. According to Annex XVI, several devices with a solely aesthetic purpose, such as coloured lenses with no corrective property, will be regulated by the MDR. However, live bacteria such as probiotics are expressly excluded from the scope of the MDR.

The MDR maintains the classification system currently in place under the Directives: medical devices are classified according to risk, from Class I (low risk) to Class III (high risk). Higher risk and implantable devices are the most affected by the requirements introduced under the MDR.

The MDR increases the number of rules and criteria used to determine the risk class of a medical device. Many medical devices will be “upclassified” under the new Regulation, i.e., moved to a higher risk class, with more stringent requirements at every stage, from ex-ante control to post-market surveillance.

The treatment of medical software under the MDR exemplifies both the expansion of the scope of the regulatory framework to reflect the state of innovation, and the imposition of heightened requirements. The MDR explicitly distinguishes between software—including apps—that serves a medical purpose and is thus considered a medical device, and software that serves a general purpose and is not considered a medical device, even when used in a healthcare setting. Typically, general fitness, lifestyle and wellness apps fall outside the scope of the MDR. In case of uncertainty, the functionality of the software, the manufacturer’s intention and any marketing claims regarding health benefits will be taken into account to determine whether the software should be regulated as a medical device. Even if a software product is not defined as a medical device, it might be considered an accessory to a medical device and therefore be subject to specific requirements under the MDR.

Many medical software products likely will be moved to a higher risk class, with stricter requirements. Moreover, many other software that were altogether unconcerned by previous EU medical laws will now be considered medical devices. Manufacturers will have to set up risk assessment procedures accordingly. The MDR outlines specific IT security measures for medical software in addition to the general requirements dependent on risk class. The EU issued guidance on cybersecurity requirements for medical devices earlier this month.

Potential Operational Difficulties for Industry Actors

The MDR places new and stricter requirements onto existing actors, and also defines new actors. It introduces the Medical Device Coordination Group, which is tasked with assisting the Commission and member states with MDR implementation, and a person responsible for regulatory compliance, which will need to be appointed by manufacturers. It increases the responsibilities of national control authorities, outlines an EU-wide procedure for multi-centre clinical investigation and strengthens the role of experts. It also clarifies the obligations of four economic operators for medical devices: the manufacturer, the authorised representative, the importer and the distributor.

Together with notified bodies, manufacturers of medical devices will be the most affected by the new rules. Under the previous Directives, manufacturers already bore the most responsibilities, and they will need to meet stricter and new requirements regarding technical documentation, labelling, risk management and clinical evaluation to comply with the MDR. They will have to follow more restrictive CE marking procedures for many devices, collect data about device performance after a product is placed on the market, and update their documentation and processes accordingly, with insufficient guidance from the European Commission so far. Manufacturers of implantable devices will also have to issue an “implant card” containing information about these devices. Many manufacturers will likely struggle to fulfil all of their obligations by 26 May 2020, fuelling concerns some might decide to withdraw from the European market altogether.

Notified bodies also face considerable challenges under the MDR. Manufacturers can only self-certify Class I devices. For any medical device of a higher risk class, a notified body must assess the product before it can receive a CE mark and be placed on the European market.

Under the MDR, much stricter rules apply to notified bodies regarding their control, oversight and evaluation missions. This represents a shift in the way notified bodies must carry out their obligations. While they previously took on a more consultative role, notified bodies will effectively enforce the new Regulation. Crucially, the MDR and the IVDR establish both the right and the obligation for notified bodies to conduct unannounced audits. This shift is likely to affect the compensation liability of notified bodies.

The MDR requires notified bodies to reapply for their status, even if they had already been approved under the Directives. Only nine notified bodies are currently designated under the MDR, with none in France so far. This is far below the approximately 20 notified bodies that the Commission expected by the end of 2019, or the 58 that held their status under the Directives. Stricter requirements, as well as the increased number of medical devices affected, have prompted several former notified bodies to announce that they would not seek designation under the MDR.

Many manufacturers will have to switch to a notified body that has received its designation under the MDR. These manufacturers will have to undergo an audit and have all their documentation reviewed by their new notified body before it can assess their products. Additionally, manufacturers will have to seek certification for thousands of upclassified medical devices they could previously self-certify.

Even if the Commission designates a dozen more notified bodies by 26 May 2020, they are unlikely to have sufficient capacity to handle the increased workload. This will lengthen the already months-long process for certification or recertification of new and existing products, thus delaying the market availability of many medical devices.

A Complex and Shifting Calendar for Application of the MDR

The MDR contains several exceptions to the general date of application of 26 May 2020. The Regulation provides for several interim phases for Eudamed, a comprehensive new database on medical devices and a key feature of the new legislation. Eudamed will store all the regulatory information relevant to a device, including a unique identification number, its manufacturer and distributors, clinical evaluation data and any certificate issued by a notified body.

The Commission announced in October 2019 that Eudamed would not be fully functional for another two years. Pursuant to the MDR, Eudamed-related interim phases will not start until notice of full database functionality is issued. The duration of interim phases varies depending on the action concerned.

MDR obligations are only postponed insofar as they relate to Eudamed. For example, manufacturers must still designate a person responsible for regulatory compliance by 26 May 2020, even though that person will not be registered until Eudamed is fully functional.

A few MDR provisions applied before the general date of application, including, for instance, provisions concerning the Medical Device Coordination Group. Several derogations apply to MDD/AIMDD-compliant devices, allowing for different transition periods depending on the risk class of the device and its situation on the market. A grace period applies to certificates issued by notified bodies before 26 May 2020. Existing medical devices with a certificate may continue to be placed on the market until 26 May 2024, provided that they remain compliant with the Directives and there is no significant change in their design or intended use. Whether a change is significant will mostly be determined on a case-by-case basis.

Pursuant to a “warehousing provision”, MDD/AIMDD compliant devices that are placed on the European market before 26 May 2020 or hold certificates issued before 26 May 2020 and benefitting from the aforementioned grace period may continue to be made available until 26 May 2025. This does not apply to the placing on the market of such devices or to second-hand sales.

The European Union recently published corrigenda meant to further alleviate the difficulties faced by the medical device industry with regard to the application of the new rules. Most notably, a corrigendum published in December 2019 allows for a four-year grace period before upclassified Class I devices must receive a certificate issued by a notified body designated under the MDR. Other changes in the calendar are unlikely.

Transition periods for MDD/AIMDD-compliant devices only relate to certification requirements. Other obligations for these devices—such as risk and quality management or clinical evaluation requirements—come into effect on 26 May 2020.

Manufacturers likely will be unable to use these exceptions to their full extent, because notified bodies will not have enough capacity to put all existing certificates through the grace period in the next four months. Class I devices that are not moved to a higher risk class do not benefit from any transition period. Even if manufacturers wish to take advantage of the warehousing provision, they might be unable to do so because of limited production capacities or a product’s short shelf life.

Post-Brexit Uncertainties

The British Parliament has officially passed the EU Withdrawal Bill. Following the approval of the Withdrawal Agreement by the European Parliament on 29 January 2020, the United Kingdom will remain bound by EU laws until 31 December 2020. The MDR will apply in the United Kingdom from 26 May 2020 until the end of this transition period. During this time, the United Kingdom and the European Union will start negotiations on a future trade agreement. The United Kingdom and the European Union may decide to extend the transition period by up to two years; such an extension must be agreed upon before 1 July 2020.

Considering the short timeframe for negotiations in the absence of an extension, there is a distinct possibility that the United Kingdom and the European Union may fail to reach an agreement before the end of the transition period. In this case, the United Kingdom would not be able to continue its participation in the EU regulatory network for medical devices, UK-based notified bodes would lose their designation, and their certificates would become void, among other consequences. The United Kingdom took steps to ensure that its rules for medical devices closely mimic those set out by the MDR in the event of a no-deal Brexit, but it might decide in the future to impose different regulatory requirements.

Even if there is an agreement, it is unlikely that UK-based notified bodies will keep their status in the European Union. UK-based manufacturers may need to have an EU27-based representative and an importer as early as 31 December 2020 if they wish to continue placing their devices on the European market. Future requirements for placing devices on the UK market are less clear but will likely involve a UK responsible person and an importer.

The McDermott Difference

Medical device industry actors face many uncertainties regarding the consequences of the MDR’s application. Our lawyers have extensive experience handling the issues faced by the global health industry. Our Paris-based regulatory and life sciences teams have received numerous recognitions and offer in-depth knowledge of the EU legislative framework. We understand the constraints that medical device manufacturers and other actors face, and are well-equipped to offer practical, concrete solutions. Our network of offices in London, Brussels and across the European Union—and beyond—enables us to handle complex cross-border matters for our clients.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDermott Will & Emery | Attorney Advertising

Written by:

McDermott Will & Emery

McDermott Will & Emery on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at:

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit
  • New Relic - For more information on New Relic cookies, please visit
  • Google Analytics - For more information on Google Analytics cookies, visit To opt-out of being tracked by Google Analytics across all websites visit This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at:

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.