The medtech sector has welcomed the vote from the European Parliament to endorse new regulations on in vitro diagnostic medical devices (IVDR) and the new Regulation on Medical Devices (MDR).
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Governing the two different types of essential health technologies for citizens, for example blood screening tests (in vitro diagnostics) and pacemakers (medical devices), the vote is seen as the final step in the process before implantation begins.
New rules will also ensure that medical devices such as breast or hip implants are traceable and comply with EU patient safety requirements were backed by MEPs on Wednesday. MEPs also approved laws to tighten up information and ethical requirements for diagnostic medical devices, e.g. for pregnancy or DNA testing.
Industry body MedTech Europe said it welcomed the news. The group’s CEO, Serge Bernasconi said: “The new Regulations are welcomed by our industry as these will strengthen patient safety and clarify access to new and innovative technologies. Medical technologies save lives, improve health and contribute to sustainable healthcare.
“The commission, the council and the European Parliament have recognised the specific and differing nature of the two types of technologies when building these two new regulations and we welcome this vote that allows industry to begin the work needed to transition the two sectors to the new rules within the set timeframes.”
The official timings for transition start 20 days after the new laws are published in the Official Journal. This is expected in early May, which means an official transition starting date around the 1st of June. The Regulations will be fully applicable in three years for medical devices and in five years for in vitro diagnostics medical devices.
The new rules for breast and hip implants are partly borne out of the widespread media scandals that have rocked the sector in recent years. The new rules include random inspections of producers’ facilities after devices have been placed on the market, and "implant cards" for patients, enabling patients and doctors to track which product has been implanted.
"The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorise medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorised”, said medical devices rapporteur Glenis Willmott (S&D, UK).
“We've also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible”. “With the PIP breast implants scandal, many women simply didn’t know if they had received defective implants or not. So we’ve also introduced a Unique Device Identification system to help trace patients, who will also be given an implant card, which they can use to access information via a publicly accessible database", Ms Willmott added.
A separate law will also ensure that the new rules om device identification also apply to in-vitro diagnostic medical devices, i.e. those that are not in direct contact with the patient, but provide health information, such as HIV, DNA or blood testing devices.
“We learned the lessons of scandals such as that of defective breast implants”, said rapporteur on in-vitro diagnostic medical devices Peter Liese (EPP, DE).
“Problems have occurred in other areas too, e.g. with stents that are implanted into the brain or unreliable HIV tests. The new regulation is good for patients, puts an end to fraudulent and shady producers and thus also strengthens respectable producers”, he added.
The legislation would also require EU member states to inform patients of the consequences of DNA tests.
"DNA tests can have severe consequences for patients’ lives and they should not be carried out without proper information and counselling. Member states pointed out that this is first of all their responsibility and that they will therefore accept EU rules only to a certain extent. It is important that member states fulfill this obligation. We will be very vigilant on this question", said Liese.
GS1 UK, part of the global not-for-profit standards organisation, has also welcomed the adoption of the final regulations.
GS1 global standards will be used by manufacturers to implement the new EU system of Unique Device Identification (UDI), which aims to support patient safety and supply chain security.
Glen Hodgson, Head of Healthcare, GS1 UK, said “Using GS1 standards for UDI benefits patients, the healthcare system and the medical device industry. We’re working with healthcare organisations to help them identify medical devices, which will help make recalls quicker and more efficient – particularly compared to the often incomplete paper-based systems often used today.”
“GS1 standards for UDI provide the foundation for a global, secure healthcare supply chain by recording accurate data for adverse events and documenting the use of medical devices in electronic health records and clinical information systems,” added Glen. “This is a huge step forward for patient safety and in the UK it will support the great improvements in efficiency that the Scan4Safety programme is already delivering throughout the NHS.”
Bruno Aceto, GS1 in Europe’s Chairman, added: “The EU has made safety and integrity of the global healthcare supply chain a strategic priority by adopting legislation for UDI for medical devices. The successful implementation of UDI by all healthcare stakeholders, from manufacturers to healthcare providers, will depend on several factors, including a globally standardised and harmonised system. The 47 national organisations composing GS1 in Europe, the European platform of GS1, are available to help companies implement the GS1 standards to answer regulatory requirements.”
GS1 UK works with healthcare manufacturers to help them create and maintain UDI numbers by following the EU regulations. According to the regulations, a UDI number must be applied to the medical device label, its packaging and, in some cases, the device itself. Required product data must be submitted to Eudamed, the central European database. GS1’s global identification and coding systems are compliant with relevant international ISO standards.
The GS1 standard for item identification (the GTIN) is used across the global healthcare industry as a unique identifier for medical and surgical products at every level of packaging. Since 2013, GS1 has been accredited as an issuing agency for UDI by the US Food and Drug Administration (FDA).
