Italy: EU Proposal For A Regulation On Medical Devices In The Field Of Active Implantable Devices: An Overview Of The Impact

Last Updated: 12 August 2013
Article by Paola Sangiovanni

The Proposal attempts to create a robust regulatory framework which will aim at ensuring a greater level of safety of medical devices, enhanced transparency and traceability, reinforcement of the role of notified bodies and of national authorities, and ultimately an improved confidence in EU regulations which greatly suffered after the PIP breast implant scandal.  Here are some of the changes that have a direct impact on active implantable devices.

REVISED DEFINITIONS.  Partially revised definitions of what constitutes an active implantable device have been introduced in order to clarify the application of the Proposal to items that may have previously been regarded as falling within grey areas:

  • active devices are devices the operation of which depends on a source of power, which includes stand-alone software (which must be state of the art and take into account the principles of development life cycle, risk management, verification and validation);
  • implantable devices now also include any device intended to replace an epithelial surface or the surface of the eye, as well as any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days.

CLINICAL INVESTIGATIONS.  Stricter rules are foreseen for clinical investigations on the device to be carried out under the responsibility of a sponsor (who can be the manufacturer or another legal or natural person taking responsibility for the clinical investigation) and in the framework of a clinical investigation plan.  Such clinical data will have to demonstrate compliance with the general safety and performance requirements.  Further, clinical investigations are subject to a unified electronic system, which will in part be accessible to the public, designed to facilitate exchange of information on investigations and events (a unified electronic system is also foreseen for registration, identification and traceability of devices, vigilance and market surveillance, and economic operators) .  Clinical investigations must be performed unless it is duly justified to rely on existing clinical data alone, but reliance on existing clinical data is less acceptable than before: the Proposal now expressly indicates that a demonstration of equivalence with another device shall generally not be considered as sufficient justification to rely on existing data.  This may address on of the concerns voiced by the FDA, which maintained that the EU system allowed devices to be placed on the market on the mere basis of laboratory testing, literature review and small clinical trials.

APPROPRIATE EXPERTISE IN THE ASSESSMENT OF AN IMPLANTABLE MEDICAL DEVICE.  The Proposal confirms the system of conformity assessment by notified bodies (rather than switching to the US-recipe of centralized pre-market approval), but emphasizes the need of actual, competent and continuous pre-market and post-market controls.  The Proposal, in fact, mandates that, where subcontractors or external experts are used in the context of the conformity assessment, in particular regarding novel, invasive and implantable medical devices or technologies, the notified body shall have adequate own competence in each product area for which it is designated to lead the conformity assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification.  Additionally, the notified body must establish procedures for assessing and monitoring the competence of all subcontractors and external experts used.

RATIONALIZATION OF INFORMATION ON THE DEVICE.  In order to increase transparency, effectiveness and availability of documentation regarding a device, certain rules of the Proposal aim at rationalizing records to be kept on active implantable devices and avoiding that controls of competent authorities drown in a sea of paper:

  • SUMMARY OF SAFETY AND CLINICAL PERFORMANCE.  The manufacturer is under a duty to draw up a summary of safety and clinical performance, which must be written in a way that is clear to the intended user.  The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment and shall be validated by that body.  This document, which will have to be more concise and clear than a user manual, will surely have consequences on product liability on active implantable devices.
  • SUMMARY OF TECHNICAL DOCUMENTATION.  The manufacturer must be able to provide, upon request by a competent authority, a summary technical documentation (STED) and grant access to the full technical documentation upon request.
  • 15-YEAR PERIOD FOR KEEPING RECORDS.  Manufacturers (or authorized representatives) must keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement available to the competent authorities for a period of at least 15 years after the last device has been placed on the market.

IMPLANT CARD.  The manufacturer of an implantable device shall provide together with the device an implant card, which must be written in a way that is readily understood by a lay person and must be made available to the particular patient who has been implanted with the device. The card has to include: (a) information allowing identification of the device, including the Unique Device Identification; (b) warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences or environmental conditions; (c) information about the expected lifetime of the device and any necessary follow-up.  Many manufacturers (e.g., in the field of pace makers) have already adopted this type of communication for many years and our guess is that they may welcome clear rules for information to patients, which institutionalize their direct contact with them.  No doubt, however, that providing information regarding the expected lifetime of a device will be difficult to convey in simple lay-person terms and will have critical consequences on product liability suits.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions