On 19 June 2015, the Council of the European Union ("Council") came to a common position, during a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), on two draft Regulations intended to replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive.
The draft Regulations were published by the European Commission on 26 September 2012. The European Parliament proposed amendments to the Commission's texts on 22 October 2013 following a vote in plenary session. The Council has discussed the proposals of the Commission since this vote.
During the EPSCO meeting on 19 June 2015, all EU Member States, except Germany and Poland agreed, to validate, as a package, the amendments prepared by the Council to the original texts of the European Commission.
If the proposed Regulations are adopted in their current form, they will lead to an overhaul of the current regulation of medical devices and in vitro diagnostic medical devices in the European Union ("EU"). Many new provisions would be introduced by the draft Regulations. An outline of some of the most noteworthy proposals concerning the medical devices industry is provided below.
Products without medical purposes
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 such as equipment of liposuction, lipolysis or lipoplasty would also be included in this Annex.
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.
New procedure for certain high risk medical devices
As in the Commission's proposals and the related Parliament amendments, the Council has proposed that the current conformity assessment procedure be strengthened for high risk medical devices. However, the Council proposed that the scope of this procedure be more limited than that proposed by the Parliament. The Parliament proposed that this 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 IVDs.
For implantable Class III medical devices, the procedure would be as follows:
- The manufacturer's notified body would prepare a clinical evaluation assessment report concerning the clinical evidence provided by the manufacturer taking into account the benefit/risk determination, the consistency with the intended purpose and the post-market clinical follow up plan;
- This clinical evaluation assessment report must then be transmitted to the European Commission which would communicate the report to an expert panel;
- The expert panel would provide a scientific opinion concerning the clinical report to the notified body; and
- The notified body would give due consideration to the views expressed by the expert panel. If necessary, the notified body may advise the manufacturer to restrict the purpose of the device to certain numbers or groups of patients, to limit the duration of validity of the certificate, to undertake specific post market clinical follow-up studies, to adapt the instructions for use or the summary of safety and clinical performance or impose other restrictions in its conformity assessment report.
The scrutiny procedure would not be required if:
- The device has been designated as a modification of a device already marketed in the EU 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 for this device is in compliance with the relevant Common Specifications.
For Class D IVDs, the revised proposal would require the manufacturer's notified body to prepare a performance evaluation assessment report. The notified body would then request a reference laboratory to verify whether the performance of the device complies with the available Common Specifications and with the state of the art. The verification would include laboratory tests by the reference laboratory. The notified body would be required to give due consideration to the views expressed in the scientific opinion when making its decision. The notified body would not deliver the CE Certificate of Conformity if the scientific opinion is unfavourable.
Single-use devices and reprocessing of devices
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 the EU Member States. The European Commission would also be 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 view of the Council concerning the reprocessing of medical devices is rather different from the views of the Parliament. Parliament proposed that medical devices would 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.
As with the Parliament's proposal, the Council also considered 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. The Council, however, introduced an exception to this principle for single use devices reprocessed and used within a health institution.
Manufacturers of Class III medical devices would be empowered to consult with an expert panel prior to the commencement of a clinical evaluation and/or investigation. The role of the expert panel would be to review the manufacturer's intended clinical development strategy and proposals for clinical investigations. The opinions expressed by the expert panel would form a 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 already marketed by the same manufacturer and accepted by the notified body as being equivalent to the marketed device;
- The clinical evaluation is sufficient to demonstrate conformity with the relevant safety and performance requirements.
- The manufacturer has access to the technical documentation of the other manufacturer on an on-going basis through a written agreement.
In these circumstances, the notified body shall determine whether the post market clinical follow-up plan is appropriate and include post market studies to demonstrate the safety and performance of the device.
European Authorised Representative
The Council has proposed additional responsibilities for the European Authorised Representative appointed by a manufacturer which is not established in the European Economic Area. In the view of 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 views, the European Authorised Representative should not only have access to the technical documentation but also keep a copy of this documentation.
If adopted, the addition of this task to the current role of the European Authorised Representatives would substantially amplify the role and responsibilities of European Authorised Representative in the EU who would be legally liable for defectives devices placed on the EU market if the medical devices were not compliant with the requirements of the Regulations.
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 Regulation for medical devices.
However, micro and small enterprises would not be required to employ a person for regulatory compliance within their organisation. Rather, there would 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 would be also required pursuant 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 would not be required to be an employee of the European Authorised Representative.
Although an agreement was reached by the Council concerning the proposed amendments to the proposed Commission Regulations, the Council must still prepare and agree on the recitals of the proposed Regulations. When the recitals are finalised, trialogue negotiations between the Council, the European Parliament and the European Commission are expected to start. This trialogue is expected to begin in autumn 2015. Depending on the outcome of the trialogue, the Regulation on medical devices and the Regulation on in vitro diagnostic medical devices could be definitively adopted in mid-2016.
If adopted, the Regulation on medical devices would be applicable three years after its entry into force. For the Regulation on in vitro diagnostic medical device, the Council has proposed a five years transition period.