European Parliament plenary vote on revised medical devices package
The draft Regulations will now be discussed by the Council of the European Union ("Council") which is scheduled to vote on the texts in December 2013. The European Commission ("Commission") expects the proposals to be definitively adopted by early 2014 in advance of the European Parliament elections in May 2014. If it proves possible to adhere to this time line the Regulation on medical devices and the Regulation on in vitro diagnostic medical devices ("IVDs") would enter into force from 2015. However, in light of the on-going differences of opinion between the European Parliament and some members of the Council it cannot be excluded that the proposals will be substantially amended before adoption.
If the proposed Regulations are adopted in their current form, they will lead to an overhaul of the regulation of medical devices in the European Union ("EU"). Many new provisions would be introduced by the draft Regulations, if adopted without changes by the Council. An outline of some of the most noteworthy proposals concerning the medical devices industry is provided below.
Scope of the Regulations
The European Parliament has proposed a new definition of "medical device". This would provide that medical devices can have direct and indirect medical purposes. The current definition of a medical device would also be amended to provide that a product providing information concerning direct or indirect impact on health would be considered to constitute a medical device. This amendment would include nutrigenetic tests and lifecycle tests within the scope of the Regulation as the Parliament considered that these tests may have, at least, indirect consequences for people's health. For the same reason, the European Parliament proposed that the draft IVD Regulation include IVDs used for DNA-testing within the scope of the Regulation.
New procedure for certain high risk medical devices
The European Parliament voted in favour of specific rules which would affect the conformity assessment procedure for implantable Class III devices, Class IIb devices intended to administer and/or remove a medicinal product, devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable and Class D IVDs where no common technical standard exists. These devices would be considered high risk medical devices under the draft Regulation. For these medical devices, the proposed conformity assessment procedure would include the intervention of special notified bodies, designated by the European Medicines Agency on the basis of specific staff qualification and training. These special notified bodies would be required to notify the European Commission of any applications for conformity assessment received from manufacturers concerning high-risk medical devices.
The European Commission would immediately transmit the notification and the accompanying documents to a newly created Medical Device Coordination Group ("MDCG") who may seek a clinical assessment from the relevant experts of a newly created Assessment Committee for Medical Devices ("ACMD"). On the basis of the ACMD assessment, the MDCG would provide an opinion on the clinical evaluation report and the post-marketing clinical follow-up plan. In its opinion, the MDCG may recommend changes to these documents. In such cases, the notified body would only be permitted to issue the relevant CE Certificate of Conformity to the manufacturer if these changes have been implemented in the documents.
New report requirements
In addition to the procedure described above, manufacturers of high risk medical devices and IVDs would also be required to draw up a report concerning the safety and clinical performance of their devices and a summary of this report. The summary of this report would be made available to the public through the European databank on medical devices ("Eudamed"). In light of the fact that it would be available to the public, the European Parliament has concluded that this summary should be easy to understand for a lay person and available in the official languages of the country within which the device is marketed.
Manufacturers of Class III medical devices would also be required to submit periodic safety update reports to the competent authorities of the EU Member States immediately upon request, or at least once a year during the first two years following the initial placing on the market of the related device. These periodic safety update reports would be assessed by the MDCG which, in case of an unfavourable assessment, would be entitled to contact the manufacturer's notified body concerning the potential suspension or withdrawal of the CE Certificate of Conformity.
Single-use devices and reprocessing of devices
According to the draft Regulation as approved by the European Parliament, medical devices would now be considered as suitable for reprocessing and as reusable devices by default, unless they are placed on a list of single-use devices which are unsuitable for reprocessing.
The Commission would set up a list of single-use devices unsuitable for reprocessing, following a mandatory consultation with the Medical Device Advisory Committee (MDAC). With the assistance of the International Medical Devices Regulatory Forum and international standardisation bodies, the Commission would also define a clear set of high quality and safety standards for reprocessing single-use devices, including specific requirements for the manufacturers of reprocessed devices.
The European Parliament also proposed that any natural or legal person who wishes to reprocess a single-use device in order to make it suitable for further use, must be considered as the manufacturer of the reprocessed device and be held liable for its reprocessing activities. As such this natural or legal person would be required to ensure the traceability of the reprocessed device and to assume compliance with the requirements of the draft Regulation, with the exception of obligations linked to the conformity assessment procedure.
New classification rules for IVDs
As proposed by the European Commission, a new risk-based classification system for IVDs would be introduced in the draft IVD Regulation. In line with the international classification proposed by the Global Harmonization Task Force, a four class system is proposed, whereby IVDs would be divided into four levels of risk: A (lowest risk), B, C and D (highest risk). Only Class A IVDs that do not have a measuring function or are sold sterile would remain subject to a self-assessment by the manufacturer.
Unique Device Identification
Manufacturers would be required to fit devices with an implant card containing a Unique Device Identification (UDI) permitting traceability and transparency of the devices. The UDI would identify the specific device, any warnings, precautions or measures to be taken by the patient or a healthcare professional and a description of potential adverse events.
The UDI would also permit all economic operators to identify those of whom they have supplied a device to and those who have supplied them with a device, including any healthcare professional or institution to whom they have supplied a device. This UDI would have to be placed on the label of the device.
This UDI system would have to be compatible with the safety features requirements introduced by Directive 2011/62/EU for medicinal products.
Irrespective of the outcome of the clinical investigation, the draft Regulation provides that, within one year from the end of the clinical performance study or from its early termination, the sponsor would be required to submit the result of the clinical investigation to the concerned EU Member States in the form of a clinical investigation report. This report would have to be accompanied by a summary presented in terms that are easily understandable to a lay person. Both the clinical investigation report and the summary submitted by the sponsor will be made available to healthcare professionals and the public through Eudamed, which will also contain information concerning serious adverse events that occurred during these studies.
Information on the reasons for early termination of a clinical investigation would have to be provided to all EU Member States, so that they can inform sponsors conducting similar clinical investigations of the results of that clinical investigation at the same time throughout the EU.
Designation and monitoring of notified bodies
The European Parliament agreed with the European Commission to impose stricter and more detailed criteria concerning the designation of notified bodies. The purpose is to improve their functionality. In line with Commission Implementing Regulation 920/2013/EU of 24 September 2013 on the designation and the supervision of notified bodies, the draft Regulations provide that a joint assessment team composed of three experts chosen by the European Commission, would be involved in the review of the documentation submitted by notified bodies in support of their application for designation by the EU Member States. At least one of these experts would be a representative of the Commission and at least one other would come from an EU Member State other than the one in which the applicant's conformity assessment body is established. The Commission representative would lead the joint assessment team. The joint assessment team would provide its final opinion regarding the assessment report and the draft notification to the MDCG who would then draft a final recommendation regarding the draft notification. The relevant national authority would base its decision concerning the designation of the notified body on the recommendation made by the MDCG.
More surprising is the proposal according to which a manufacturer who applies to a notified body established in an EU Member State other than that in which the manufacturer is registered, would be required to inform the competent authority in its own EU Member State about the application.
Person responsible for regulatory compliance
All manufacturers would be required to appoint a person responsible for regulatory compliance. This person would have the "requisite expertise" in the field of medical devices which may be demonstrated by appropriate qualifications or professional experience in medical device regulation.
European databank on medical devices
The draft Regulations propose increased transparency by requiring more information to be shared in Eudamed, which will be become accessible to the public. This would include information concerning medical devices placed on or removed from the EU market, information on notified bodies' subsidiaries and subcontractors, CE Certificates of Conformity issued by the notified bodies, information concerning on-going clinical investigations conducted with medical devices, vigilance data, market surveillance activities, Field Safety Correction Actions, Field Safety Notices, periodic safety update reports, Manufacturer's Incident Report and Manufacturers' Trend Reports.
New Essential Requirements
The European Parliament also proposed to introduce some new additions to the Essential Requirements. As an illustration, the draft Regulation provides that the Instructions for Use should be easy to understand for a lay person and be reviewed by the representatives of relevant stakeholders, including patient and healthcare professionals' organisation. It also proposed that the CE Mark would be accompanied by the term "Medical Device".
We will continue to monitor the debate within the Council closely as it cannot be excluded that the draft Regulations will be substantially amended prior to final adoption.