Joint CAMD/HMA statement published on status of EU Regulatory System

The Competent Authorities for Medical Devices (CAMD) and the Heads of Medicines Agencies (HMA) have published a joint statement on the current status of the EU regulatory system for medical devices and in vitro medical devices.

The statement, copy available from here, makes it clear that “there are challenges in applying the Regulations for all stakeholders and the competent authorities are strongly committed to work to resolve issues, develop and
secure the regulatory system.”

The statement continues that “Significant delays in progression and practical application of the new regulatory framework have been experienced; costs have increased for all parties, with little transparency or predictability; this, together with planning challenges and capacity shortfalls at various points in the system, has contributed to uncertainty and hesitation in transitioning.”

The statement concludes that “We stand ready to support and work with the Commission through the targeted evaluation and other initiatives to carefully assess and identify further measures to ensure that the regulatory system achieves its objectives, is applied efficiently in practice, affords appropriate public health and safety, serves the needs of its stakeholders, retains credibility and secures recognition and reliance on the regulatory system both within Europe and globally.”