For medical devices ("MDs") the law at European Union level is contained in three separate EU directives. These laws are under review and two new regulations have been proposed, one on MDs and the other on in vitro medical devices ("IVMDs").
The European Parliament debated certain amendments to the draft regulations on the 22 October 2013 and the vote on the regulations is likely to take place in 2014. It appears highly likely these regulations will be passed and, if they are, will come into force three years later. Accordingly, they could be in force by 2017. The aims of the new regulations are to:
- to increase transparency for manufacturers, notified bodies and national authorities;
- to restore public confidence (in light of recent problems with defective devices); and
- to harmonise the law across the European Union (the regulations will be directly applicable in the member states).
Additionally, a broader range of products will be covered by the regulations. With the increased scope and more onerous obligations, companies in the device sector should consider a suitable timetable for implementing the changes required to ensure full compliance when the regulations come into force.
Key changes under the proposed regulations
- Regulated devices will cover a wider range of products:
These will include products such as non-corrective contact lenses, aesthetic implants, software used indevices and possibly certain standalone software. The principle behind this is to encompass as many products as devices to stop damaging incidents occurring (the PIP implant scandal for example) as well as protecting the user from health issues (noncorrective contact lenses can lead to eye diseases if incorrectly used/manufactured). The Commission will have the final say as to whether a product is classified as a MD/IVMD.
- The scope of the regulations is likely to be clearer than the current directives. There was too much uncertainty as to which category a particular device would be classified as, and the powers of notified bodies varied from member state to member state.
IVMDs will be classified due to their level of risk. Devices currently on the market may be reclassified if necessary. Distance selling will be covered by the new regulations so any sales made online will need to comply with the regulations. The old law allowed certain products to be advertised online pre-conformity assessment. Devices only needed to conform with EU laws at the time of sale.
- More extensive investigation will be required to obtain a CE mark.
For medium to high or high risk devices clinical and safety data will be required and this data will be made publically available. Any new application for the conformity of a high risk device received by a notified body must be referred to an expert committee (the Medical Device Coordination Group ("MDCG")). That committee will be able to ask the notified body submit its assessment on the device for comments (if a valid scientific health question is raised) before any certification can be given.
- Higher requirements for pre-market and continuous post-market assessments of all devices.
Extensive clinical trials will have to been conducted and the analysed data (along with safety data) will be made available to the public before sale. The manufacturer will have to undertake observation studies, continuously assess risk, hazards and performance post-market. Post-market clinical follow up (including the sending of analysed data to concerned member states, publishing their findings and making this available to health professionals).
- The creation of the multidisciplinary Medical Devices Advisory Committee composed of representatives relevant stakeholders and scientific experts.
This committee will provide advice to the MDCG, the Commission and Member states regarding medical technology and the implementation of the regulations.
- A creation of special notified bodies.
These bodies will be in charge of conformity assessment for higher risk devices. They will be designated by the EMA and will consist of clinical experts and product specialists. MDs/IVMDs classified as class III/D, all devices that are implantable and/ or incorporating a substance and class IIb/C devices administering/removal medical products and nonviable tissue/cells (human and non-human) have to be assessed by a special notified body. These bodies must notify the Commission for any new class III/D and send instructions, safety and clinical data to the MDCG for assessment.
- All notified bodies will have greater powers and responsibilities:
For example, they will have the ability to perform random unannounced factory audits and to require sample data of high risk devices during inspections. They will have the power to conduct physical or laboratory tests on devices at any time (pre or post marketing) and can demand more documentation and audits from companies before making an assessment. They will also have to right to refer any device to the MDCG for further analysis. They will also need to have competent in-house personnel on a permanent basis reducing the need for sub-contracting to experts and they will be more vigorously regulated by the relevant national authority and the Medical Device Coordination Group.
- There will be clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors.
For example, each will require a "person responsible for regulatory compliance" who has the requisite expertise on the devices to ensure batch conformity, vigilance reporting obligations are fulfilled and technical documental and declarations of conformity are drawn up and updated. These persons will need to either have suitable relevant formal qualifications or three years of professional expertise in regulatory affairs or in quality management systems relating to medical devices. Also every non-custom-made device must be labelled with a unique device identifier so the supplier can be traced and devices can be recalled if necessary.
- Registers will be systematically established (EU-wide) for class IIb/C and III/D devices.
- Higher requirement for clinical performance studies (clinical trials) for procedures with significant risks (aspinal tap for example). An ethics committee and a committee for the protection of minors would need to be consulted before any trials can take place.
- The devices will be relabelled into two categories, single-use and reusable. Companies will no longer be able to label reusable devices as single-use to try to avoid liability if they are reused (and the European Commission will state what devices are not reusable).
- Manufacturers will still have the freedom to choose which notified body to submit their device to for assessment.
The new laws will ensure that a larger range of products will be classified as devices and regulated in kind. Therefore, companies who did not deal in devices previously may find that they will do under the new laws. The more strenuous process of receiving approval for new devices (in particular high risk devices) and the necessity of providing clinical data to the public will hopefully restore public confidence in all devices, but will increase time and cost to the manufacturer.
There will be a larger emphasis on both pre and postmarketing analysis which will allow devices to be monitored continuously, which should prevent adverse incidents occurring, and allow a swifter response to any that do. Companies should implement the necessary systems for compliance as soon as it is practicable so any unforeseen delays/issues can be remedied before the regulations become enforceable. It appears that due to the more strenuous regulations and conditions, approval and certification of devices will take longer and gaining such approval and certification will be a more costly process.