Products without medical purpose
New procedure for high-risk medical devices
Single-use devices and reprocessing of devices
European authorised representative
Person responsible for regulatory compliance
On June 19 2015, during a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), the Council of the European Union reached a common position on two draft regulations intended to replace the EU Medical Devices Directive,(1) the EU Active Implantable Medical Devices Directive(2) and the EU In Vitro Diagnostic Medical Devices Directive.(3)
The draft regulations were published by the European Commission on September 26 2012. The European Parliament proposed amendments to the commission's texts on October 22 2013 following a vote in plenary session. The council has subsequently discussed the commission's proposals.
During the EPSCO meeting, all EU member states except Germany and Poland agreed to validate the amendments as a package.
If the proposed regulations are adopted in their existing form, they will lead to an overhaul of the regulations on medical devices and in vitro diagnostic medical devices in the European Union, as well as the introduction of many new provisions.
The council has proposed to extend the scope of the regulation on medical devices to groups of products which are not intended to have a medical purpose. These products would be listed in Annex XV of the regulation and include contact lenses or other articles intended to be introduced into or onto the eye. Equipment intended to be used to reduce, remove or destroy adipose tissue (eg, through liposuction, lipolysis or lipoplasty) will also be included in Annex XV.
The council has proposed that common specifications be adopted for these groups of products, taking into account the state of the art and existing standards for analogous devices with a medical purpose.
As in the commission's proposals and related Parliament amendments, the council proposed that the existing conformity assessment procedure be strengthened for high-risk medical devices. However, the council proposed that the scope of the procedure be more limited than that proposed by Parliament. Parliament proposed that the procedure apply to:
- 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 in vitro diagnostic medical devices where no common technical standard exists.
The council took the view that the procedure should apply only to implantable Class III medical device and Class D in vitro diagnostic devices.
For implantable Class III medical devices, the procedure will be as follows:
- The manufacturer's notified body prepares a clinical evaluation assessment report concerning the clinical evidence provided by the manufacturer, taking into account:
- the benefit and risk determination;
- consistency with the intended purpose; and
- the post-market clinical follow-up plan.
- The clinical evaluation assessment report must be then transmitted to the commission, which will communicate the report to an expert panel.
- The expert panel provides a scientific opinion concerning the clinical report to the notified body.
- The notified body then gives due consideration to the views expressed by the expert panel. If necessary, it may advise the manufacturer to:
- restrict the purpose of the device to certain numbers or groups of patients;
- limit the duration of the certificate's validity;
- undertake specific post-market clinical follow-up studies;
- adapt instructions for use or the summary of safety and clinical performance; or
- impose other restrictions in its conformity assessment report.
The scrutiny procedure is not required if:
- the device has been designated as a modification of a device that has already marketed in the European Union by the same manufacturer for the same intended purpose, if the modifications have been demonstrated by the manufacturer and accepted by the notified body as not adversely affecting the benefit/risk ratio; and
- the principles of the clinical evaluation of the device type or category have been addressed in common specifications and the notified body confirms that the clinical evaluation of the manufacturer complies with the relevant common specifications.
For Class D in vitro diagnostic devices, the revised proposal requires the manufacturer's notified body to prepare a performance evaluation assessment report. The notified body then requests a reference laboratory to verify whether the performance of the device complies with the available common specifications and state of the art. Verification includes laboratory tests by the reference laboratory. The notified body must give due consideration to the views expressed in the scientific opinion when making its decision. The notified body cannot deliver the CE certificate of conformity if the scientific opinion is unfavourable.
According to the draft regulation on medical devices as amended by the council, reprocessing and further use of single-use devices may take place only when permitted by member states. The commission is also required to establish and regularly update a list of categories or groups of single-use devices which cannot be reprocessed safely and may therefore not be reprocessed.
The council's view concerning the reprocessing of medical devices differs from that of Parliament. Parliament proposed that medical devices be considered 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.
As with Parliament's proposal, the council also considered that any natural or legal person wishing 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 the reprocessing. However, the council introduced an exception to this principle for single-use devices which are reprocessed and used in a health institution.
Manufacturers of Class III medical devices will be empowered to consult with an expert panel before commencing a clinical evaluation or investigation. The role of the expert panel will be to review the manufacturer's intended clinical development strategy and proposals for clinical investigations. The opinions expressed by the expert panel will form part of the clinical evaluation report to be submitted as part of the technical document.
The council has also proposed that manufacturers of implantable devices and devices falling within Class III be permitted to rely on clinical data concerning an equivalent device if:
- the device has been designated as a modification to a device that has already marketed by the same manufacturer and accepted by the notified body as equivalent to the marketed device;
- the clinical evaluation is sufficient to demonstrate conformity with the relevant safety and performance requirements; and
- the manufacturer has access to the technical documentation of the other manufacturer on an ongoing basis through a written agreement.
In these circumstances, the notified body must determine whether the post-market clinical follow-up plan is appropriate and include post-market studies to demonstrate device safety and performance.
The council has proposed additional responsibilities for the European authorised representative appointed by a manufacturer which is not established in the European Economic Area. According to the council, the European authorised representative should be responsible for verifying that the EU Declaration of Conformity and technical documentation have been drawn up by the manufacturer and, where applicable, that an appropriate conformity assessment procedure has been conducted by the manufacturer. In the council's view, the European authorised epresentative should have access to the technical documentation and keep a copy.
If adopted, the addition of this task to the role of the European authorised representatives would substantially amplify the responsibilities of European authorised representative in the European Union, which would be legally liable for defective devices placed on the EU market if the medical devices did not comply with the requirements of the regulations.
All manufacturers will be required to appoint a person responsible for regulatory compliance. This person must have the requisite expertise in the field of medical devices, which may be demonstrated by appropriate qualifications or professional experience in medical device regulation.
However, micro and small enterprises will not be required to employ a person for regulatory compliance within their organisation. Rather, there will be a requirement to ensure that such a person remains both permanently and continuously at the disposal of the micro and small enterprise.
European authorised representatives will be also required to ensure that at least one person remains at the disposal of the organisation and is responsible for regulatory compliance activities. Such availability must be on a permanent and continuous basis. However, such person need not be be an employee of the European authorised representative.
Although an agreement was reached by the council concerning the proposed amendments to the proposed regulations, the council must still prepare and agree on the recitals. When the recitals are finalised, trialogue negotiations between the council, the Parliament and the commission are expected to start. Negotiations are expected to begin in Autumn 2015. Depending on their outcome, the medical devices regulation and in vitro diagnostic medical devices regulation could be adopted in mid-2016.
If adopted, the medical devices regulation will be applicable three years after its entry into force. For the in vitro diagnostic medical devices regulation, the council has proposed a five-year transition period.
For further information on this topic please contact Fabien Roy or Elisabethann Wright at Hogan Lovells by telephone (+32 2 505 0911) or email ([email protected] or [email protected]). The Hogan Lovells website can be accessed at www.hoganlovells.com.
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