Brett Rowland and Magdalena Gray, Eversheds LLP, outline the changes to the law on medical devices in the EU and what this will mean for manufacturers.
The recent vote in favour of new regulations for medical devices demonstrates a commitment to a more transparent and synchronised approach by the European Union. In turn this seeks to restore public confidence after a turbulent period in the industry. However, with this broader scope comes a greater onus on those producing medical devices. This article takes a look at the major changes the new laws will bring and how they will affect manufacturers.
The law at European Union level for medical devices (MDs) is contained in three directives. However, in 2012 the European Commission published its proposals for two new regulations – one on MDs and the other on in vitro medical devices (IVMDs).
EU Parliament has now voted in favour of the regulations, which are expected to be in force by 2017.
The aims of the regulations are to: increase transparency for manufacturers, notified bodies and national authorities; restore public confidence in light of recent defective devices; and harmonise the law across the EU (they will be directly applicable throughout member states).
To ensure compliance with the more onerous obligations and broader scope, companies in the device sector will need to consider a timetable for implementing the changes.
Major changes under the regulations include:
- Regulated devices will cover more products, including non-corrective contact lenses; aesthetic implants; software used in devices; and possibly certain standalone software. The Commission will have the final say as to whether a product is classified as a MD/IVMD but by regulating more devices it is hoped fewer damaging incidents (eg. the PIP implant scandal) will occur, and more users will be protected from health concerns from incorrectly manufactured/used devices.
- Greater clarity on how devices are classified, and how powers of notified bodies vary between member states. IVMDs will be classified dependent on their risk, and devices currently on the market may be reclassified if necessary. Distance selling will be covered, therefore sales made online will also need to comply with the regulations. Previously certain products could be advertised online with a pre-conformity assessment.
- A more extensive investigation will be necessary to obtain a CE mark. For medium to high or high risk devices, clinical and safety data will be required and publically available.
- Higher requirements for pre and post-market assessments of devices will exist. Extensive clinical trials will have been conducted and the data will be publicly available before sale.
- A creation of special notified bodies 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.
- Notified bodies will be more vigorously regulated, but will be able to perform unannounced factory audits and sample data during inspections. They may conduct tests on devices at any time and can demand more documentation before making an assessment.
- There will be clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors. Each will require a suitably qualified person (either through formal qualifications or professional expertise) to ensure compliance with batch conformity, reporting and technical document declarations.
- 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.
- Devices will be relabelled into two categories, single-use and reusable. Companies will not be able to label reusable devices as single-use to avoid liability if they are reused (and the Commission will state which devices are not reusable).
Businesses who previously did not deal in devices may do under the new laws. The more demanding process of device approval and the obligation to disclose data seeks to restore public confidence, but will also increase time and cost to the manufacturer.
Companies should implement the necessary systems for compliance as soon as practicable so that any unforeseen delays/issues can be remedied before the regulations become enforceable.