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MEDICAL DEVICES: on the way to improving patient safety in Europe…


Industry responded with relief to latest developments affecting new legislation on medical devices: At the end of October, the European Parliament in its plenary assembly settled on a compromise that appears to lessen the expected burden on industry. Earlier plans put forward by a parliamentary committee, which did not find consensus, had envisaged to give European Medicines Agency (EMA) a leading role in assessing risky devices, comparably to the US FDA system. 

This idea faced strong opposition by industry group EUCOMED, representing the medical technology industry in Europe. It argued that a complicated scrutiny process with a case-by-case centralized pre-marketing authorization system would primarily create heavy bureaucracy, high costs and eventually result in delay of innovation. Ms Roth-Behrendt (S&D), the German Member of European Parliament responsible for the medical devices dossier expressed some disappointment that a system advocating preliminary authorisation for high risk products was not appreciated in this first battle on a new legislation.

Nevertheless, the European Parliament advocated strengthening regulatory controls on medical devices, including unannounced inspections, to increase the ability to trace the product back to its supplier and to improve the system on information to patients. MEPs also voted for tightening up information and ethical requirements for diagnostic medical devices used for in vitro testing. Most of these measures were welcomed by industry.

Johnson & Johnson, Siemens Healthcare, Baxter, Roche and Abbott are among the major players in the area of medical devices and diagnostics producing a broad range of products such as orthopedics, dental instruments and orthodontics, diagnostic products such as blood glucose testing strips, surgical supplies and instruments, vascular stents, implantable devices used in cardiac procedures, and many more products. But there are also many small and medium-sized companies active in the medical devices sector.

So far, the European Union is operating under a regulatory framework for medical devices established by three directives in the 1990s. It was about time to adapt the rules to technological progress, also with a view to reach a more harmonized system in a single market. Then the PIP scandal added pressure on the European Commission to quickly table plans for new legislation: French breast implant manufacturer Poly Implant Prothèse, S.A. (PIP) used industrial gel in the production of breast implants instead of medically approved gel. The EU’s current system to authorize devices came under criticism as it appears to be less strict than in the US. Suddenly all eyes were turned on the business of the so-called ‘notified bodies’ who apparently failed to do their job properly. A notified body conducts conformity assessments allowing manufacturers to affix the CE mark to their devices and place them on the European market. There is a general consent on the need of stricter rules to regulate the 80 notified bodies for medical devices in the European Union.

In September last year, the proposals for medical devices and IVDs were published: The European Commission proposed a Regulation on medical devices to replace Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices. At the same time, also a proposal for a Regulation on in vitro diagnostic medical devices to replace Directive 98/79/EC regarding in vitro diagnostic medical devices was published. Regulations instead of directives imply legislation to become directly in force across all countries in the European Union, whereas directives must be transposed into national law in each member state, which leads to different interpretations and a variety of implementing laws.

Proposed measures by the European Commission include a mandatory identification of the supply chain, improved traceability by way of Unique Device Identification, registration of manufacturers, importers and devices in an EU database, better supervision of the notified bodies, more transparency of clinical data and reporting of serious adverse reactions by patients and health professionals. 

One of the main controversial topics is whether pre- and post-market assessments and surveillance measures can achieve the right balance between clear, enforceable rules for patient safety and an incentive for Europe’s innovation potential. Industry backs the Commission's goal of improving standards at notified bodies, but prefers to avoid introducing an extra layer of scrutiny, moving from a pre-market product scrutiny to a post-market system scrutiny based on post market controls.

After the European Parliament’s ‘first reading’, the ball is now at the Council gathering the health ministries of 28 EU Member States, and there is pressure to adopt the new legislation according to the so-called ordinary legislative procedure – requiring joint decision-making by EU institutions – before a new European Parliament will be elected next year. Apart from the approval system, many other important issues remain to be solved, such as the question of reprocessing devices. So, the legislation is likely to be substantially amended before adoption, in an attempt to find a balanced solution that benefits both, patients’ security and industry, and facilitates future innovation in devices.



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