Initiated against the backdrop of the well-documented PIP breast implant issues, the new Regulations have been the subject of rigorous scrutiny and comment for the past four years. On 14 June 2016, the agreed texts of the Regulations were finally published on the Parliament's website which brings us closer to, arguably, the biggest legislative overhaul in the history of the medical device industry.

Further to our previous alert on this issue, below are some of the key elements of the new Regulations on medical devices and in vitro medical devices.

DEFINITION OF MEDICAL DEVICES EXPANDED

The definition of medical devices is expanded to include, amongst others, devices with purposes related to prediction and prognosis of diseases. This will have a significant impact on quantification products and services in the field of health-related parameters which could now fall within the scope of the new Regulations. Companies operating in the mHealth sector would also be advised to bear in mind any potential impact the draft European Commission guidelines on mHealth may have on their products.

The Regulations will also apply to a group of products without an intended medical purpose that are listed in Annex XV, such as contact lens,

equipment for liposuction and products used for tattooing. These products will have to meet common specifications that address risk management and, where necessary, clinical evaluations regarding safety.

REPROCESSING

Reprocessing represented one of the most contentious points during the negotiations with some stakeholders strongly in favour of allowing reprocessing by default while others were strongly against such activities without the consent of the individual Member States.

Reprocessing refers to enabling a device to be safely reused through cleaning, disinfection, sterilisation and related procedures, including testing and restoration of the technical and functional safety of the previously used device.

According to the text of the new Regulations, reprocessing of devices will only be permitted in accordance with individual Member State legislation which may prohibit such reprocessing. The Commission is tasked with drawing up a report within four years after the date of application of the Regulations on the operation of these provisions and submit it to the European Parliament and to the Council for consideration.

NOTIFIED BODIES

The Regulations will further tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market (the so-called "notified bodies"). The Regulations introduce stricter designation requirements for these bodies and it remains to be seen whether current notified bodies will have the capability and competence to meet these new requirements.

The rules will give these bodies the right and duty to carry out unannounced factory inspections. While this is something that is happening already, companies need to be prepared for this type of "dawn raid".

HIGH RISK DEVICES

Controversially, certain high-risk devices, such as implants, may undergo an additional check by experts before they are placed on the market.

The conformity assessment procedure for these devices can include the intervention of expert panels, designated by the European Commission. Notified bodies may seek advice from an expert panel on applications for conformity assessment for such devices. The notified body shall give due consideration to the views expressed by the expert panel.

Where the expert panel raises concerns about certain matters such as the sufficiency in the level of clinical evidence or serious concerns about the benefit/risk determination of the device, the notified body is required to advise manufacturers to take certain action to address those concerns. In the event that the notified body has not followed the advice of the expert panel, the notified body shall provide a full justification.

In addition to the above procedure, a newly created Medical Device

Coordination Group ("MDCG") and, where applicable, the European Commission, may independently request scientific advice from the expert panels in relation to the safety and performance of any such high risk devices.

UNIQUE DEVICE IDENTIFICATION FOR DEVICES

Manufacturers will be required to place a Unique Device Identification ("UDI") on their medical devices to ensure traceability. The UDI will need to be included on the label of the device. Entities involved will be able to identify from whom and to whom a device has been supplied in a "one step back"-"one step forward" approach.

The UDI will include information concerning the identity of the device, any warnings, precautions or measures to be taken by the patient or a healthcare professional and a description of potential adverse events.

CLINICAL INVESTIGATIONS

With a backdrop of increasing transparency in the area of clinical trials for medicinal products, the new Regulations aim to improve the availability of clinical investigation data on devices.

Sponsors of clinical investigations will be required to publish the results of clinical investigations and a summary of the results in layman's language on Eudamed which will be available to the public. Eudamed is a database for information on medical devices collected by competent authorities and the European Commission. Presently, only such competent authorities and the European Commission have access to Eudamed. The Regulations will now grant access to Eudamed to a broader spectrum of stakeholders, including members of the public.

These documents must be published on Eudamed regardless of the outcome of the investigation and must be done within one year from the end of the investigation or within three months from its early termination or halt, whichever is the earliest.

NEXT STEPS AND TIMELINES

The Regulations still have to be formally adopted by the Council and the Parliament which is expected to be completed by the end of this year following legal review and language translations in the coming months. It is widely anticipated that the Regulations will be adopted without any major alterations to their current form.

The new rules will apply three years after publication for medical devices and five years after publication for in vitro diagnostic medical devices.