Modernising EU rules for medical devices
In 2012, the Commission presented a package consisting of two legislative proposals accompanied by a communication.
Its aim is to modernise the current legislation to make sure that medical devices and in vitro diagnostic medical devices are safe, can be traded across the EU and that new innovative devices reach patients in a timely manner.
The package covers a broad range of products: from plasters and pregnancy tests, to state-of-the-art pacemakers, X-ray machines and genetic tests.
The proposed law would increase the scrutiny of products before they enter the market and tighten surveillance once they are available. It also wants to create a unique device identification system that makes it easier to recall faulty products and helps to fight against counterfeit devices.
Why is it needed?
The recent scandals related to metal-on-metal artificial hips or faulty silicone breast implants have strengthened the case for modernising current rules for medical devices.
Today's medical devices and in vitro diagnostic medical devices are becoming ever more sophisticated and innovative. Existing rules date back to the 1990s and have not kept pace with scientific and technical developments in the healthcare sector.
Under current rules, it's not always possible to establish who produced devices sold in the EU, and there is a shortage of information and clinical evidence showing that they are safe and effective. Several member states have set up electronic registration tools. However, these tools are not always compatible with each other, making traceability across borders difficult. The use of different systems in different countries also place an unnecessarily heavy burden on producers who want to market a product in more than one country.
Medical devices in the EU in figures
- there are over 500 000 medical and in vitro diagnostic devices on the market
- the sector employs over 500 000 people in about 25 000 companies, most of which are micro, small and medium sized enterprises
- they generate nearly €100 billion in annual sales in the European market
- about 6-8% of medical devices annual sales and 10% of in vitro devices annual sales is re-invested in research every year
Unlike pharmaceuticals, medical devices and in vitro diagnostic medical devices are not subject to pre-market authorisation. Instead, they undergo a conformity assessment to establish whether they meet the applicable standards. Depending on the risk posed by a product, the assessment may involve a so-called 'notified body', e.g. a laboratory, a national standards authority or the like, which performs the conformity assessment. However, the rules which determine the scope of controls carried out by these bodies vary from one country to another.
In addition to improving the safety of medical devices, the draft legislation seeks to stimulate innovation.
It is estimated that in 2060 there will be twice as many Europeans aged 65 or over, increasing the importance of medical devices and in vitro diagnostic medical devices for public health and medical care.
Proposal for a regulation on medical devices - 2012/0266 (COD)
Proposal for a regulation on in vitro diagnostic medical devices - 2012/0267 (COD)
The draft regulations place a special focus on:
- pre-market conformity with requirements
- post-market oversight
- traceability of medical devices and in vitro diagnostic medical devices throughout the supply chain
The proposed legislation classifies in vitro diagnostic medical devices in 4 risk categories, in line with the categorisation that already exists for other medical devices.
The risk level of a device would determine:
- the obligations placed on manufacturers and other economic operators
- the requirements for clinical investigations and clinical evidence
- the requirements for market surveillance by national authorities
Under the proposed legislation each business would be required to appoint a qualified person in charge of ensuring compliance with the requirements in force. Depending on the risk class of a device, the conformity is assessed either by the manufacturer or an independent organisation, so-called 'notified body'.
The proposed legislation allows reprocessing of certain single-use devices, which aims to make them suitable for further use, provided they meet the obligations applicable to new devices.
In a bid to trace devices, the proposed regulations require manufacturers and importers:
- to fit their products with a Unique Device Identification (UDI)
- to register themselves and the devices they market in the EU in a central European database
- to be able to identify who supplied them with a product and to whom they have supplied it
Manufacturers would also be required to use a new EU portal to report serious incidents and corrective actions they took to prevent recurrence.
The proposed legislation aims to clarify and strengthen the powers of notified bodies.
The notified bodies would be required to certify various aspects of medium and high-risk devices before they enter the market and to check their safety and performance once they are on the market. New rules allow the notified bodies to carry out unannounced factory inspections and make physical or laboratory tests on devices.
The rules on checks carried out by notified bodies would be strengthened across the EU and aim to ensure a level playing field.
Member states will continue to designate and monitor notified bodies. However, the corresponding decisions would be subject to 'joint assessments' by experts from the country designating the notified body, other countries and the European Commission.
Medical Device Coordination Group
The draft regulations propose to create a Medical Device Coordination Group comprised of national representatives. One of the proposed tasks for this group is to have a second look at assessments of high-risk devices carried out by notified bodies before they are placed on the market.
The existing European data bank on medical devices (Eudamed) will get additional functions related to the UDI system, to the registration of devices and economic operators, to market surveillance and vigilance, relevant certificates and clinical investigation. The intention is also to make all non-confidential information public.
In the Council
The proposal follows the ordinary legislative procedure, which means that the Council and the Parliament decide as co-legislators.
The Council's preparatory work is being carried out by the Working Party on Pharmaceuticals and Medical Devices.
During discussions at the Employment, Social Policy, Health and Consumer Affairs Council, ministers stressed the importance of striking the right balance between reinforcing patient safety and accelerating access to new innovative devices.
They also discussed ways of strengthening the pre- and post-market supervision processes.
During discussions, most member states were in favour of clarifying the procedures for designating the 'notified bodies'. They also supported greater cooperation between member states and mutual checks of notified bodies to ensure that they meet similar standards throughout the EU.
Reprocessing of medical devices designed for single use has also been discussed and many delegations expressed concerns.
Agreement with the EP
At its meeting in June 2015 the Council agreed the substance of its negotiating stance.
On 23 September 2015, the Permanent Representatives Committee finalised the Council's position on two draft regulations aimed at modernising EU rules on medical devices and in vitro diagnostic medical devices. This allowed the Luxembourg presidency to start talks with the European Parliament.
The key elements of the Council's agreement include:
- tightened rules for the designation of notified bodies and for the monitoring of their activities by relevant national authorities
- extra provisions on producers' responsibilities for the follow-up of the quality, performance, and safety of devices placed on the market
- strengthened rules on clinical investigation seeking to increase the availability of reliable clinical data on medical devices
- the requirement for producers and importers of devices to register themselves and their products in a central EU database
- the setting-up of an EU portal where serious incidents and corrective actions by manufacturers will be reported
Negotiations continued under the Dutch presidency, which started on 1 January 2016.
On 25 May 2016, the Netherlands presidency of the Council and representatives of the European Parliament agreed new rules on medical devices and in vitro diagnostic medical devices.
On 15 June 2016, the Council's Permanent Representatives Committee endorsed the agreement reached with the European Parliament. The Commission stated that it can also support the agreement reached between the two co-legislators.
Since the agreement has been confirmed by the Parliament's ENVI committee, the Council will approve the agreement at ministers' level. This is planned for September, once the draft regulations have been translated into all official languages. After their legal-linguistic revision, the new regulations will have to be approved by the Council and the European Parliament. They will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.