European Regulatory Update: RAPS, EU "Recast"
Jacqueline Minor, Director of Consumer Affairs, DG SANCO, Health and Consumers, European Commission presented at the RAPS Annual Conference (24 October 2011). She prepared the audience for the revision of the Directives and verified much of the recent circulating information. In the introductory remarks, Ms. Minor noted that the intent of the revision was to strengthen the existing EU regulatory system and recognized the many attributes of the system. She noted the EU would continue to support innovation as well as rapid access to the market while balancing pre- and post-market control and cost effectiveness.
In the EU, 80 percent of the medical device manufacturers are small to medium sized enterprises (SME) and it is appreciated that the legislation cannot be prohibitively burdensome. That said, there are clearly identified weaknesses in the system, which are the targets of the revision. Contrary to popular belief, she emphasized that the revision is not expected to be a “Recast" as this would not be the appropriate mechanism. Ms. Minor also posed that the revision would likely result in two regulations: one for medical devices and active implantable medical devices, and another for in vitro diagnostic (IVD) devices.
Under the revised system, a Regulation would be applicable to the EU member states as written and would not require transposition; this would facilitate EU harmonization. However, if the medical device directives are not recast, and regulations are the regulatory mechanism used, every aspect of the legislation would be subject to discussion. These scenarios would be evaluated though it would appear the EU Commission will propose two regulations.
The EU Commission has completed (September 2011) the Impact Assessment of the medical devices directive revision, which is a prerequisite of a new initiative. All EU Commission sources indicate the draft Regulation is expected to be published in April or May 2012. At that time, the Impact Assessment will also be released. It is believed that the draft text will include within its scope the following (previously unregulated): products with non-viable human tissue or cells, aesthetic products, in-house laboratory test, genetic tests with a diagnostic purpose, and diagnostic services where the (sample mailed outside the EU) assessment is performed outside the EU. Additionally, a decision about reprocessing single use devices is expected.
There was a discussion regarding several areas where improvements were to be made: oversight of Notified Bodies, clinical investigations, post-marketing safety, transparency, and a centralized agency. For multi-site clinical investigations, the proposal is to designate a lead Competent Authority to perform the initial technical assessment. The EU Commission has suggested that certain aspects of Eudamed would be made public. Further, the EU Commission would consider unique device identifiers (UDI). The Commission is also considering enhanced engagement of Competent Authority post-marketing safety through central reporting of incidents by manufacturers and more consistent review and assessment of vigilance. To address long-standing issues of inconsistency among Notified Bodies, it was suggested that increased oversight of Notified Bodies is needed by stipulating minimum requirements as well as more consistent designation and monitoring, perhaps by a European group.
For the administrative, technical, and support entity, the EU Commission presented two possible candidates for a centralized agency, a group within the European Medicines Agency (EMA) or within the Joint Research Centre (JRC).