Following recent developments regarding breast implants and metal-on-metal hip joint replacements, the European Parliament (EP) adopted a resolution calling for safer medical devices and the introduction of a marketing authorization system for high-risk devices. While the Commission has not endorsed the EP’s resolution for a premarket authorization system in its Proposal for a new EU medical devices’ regulation, described in our previous post, it still had to take into account the strong call from the public for safer and more strictly controlled medical devices. As a result of this political imperative, the Commission included in Article 44 of its Proposal a so-called “scrutiny procedure.” Like the rest of the Proposal, the scrutiny procedure would become law if adopted by the European Parliament and the Council. Our earlier post on the legislative process describes this procedure in more detail.
Under the scrutiny procedure, any new applications for conformity assessment of high-risk devices (with the exception of applications to supplement or renew existing certificates) would now possibly be subject to a “second look” by the Medical Devices Coordination Group (MDCG). This newly created expert committee would be composed of Member State officials and chaired by the European Commission. The Commission will probably also develop some centralized scientific and technical expertise that will allow it to be more directly involved in the assessment of specific products.
In practice, the notified bodies (independent third-parties involved in the assessment of medical devices) would have to inform the MDCG of any new applications for high-risk medical devices. Within 28 days after receipt of this information, the MDCG would be able to request the notified bodies to submit a preliminary conformity assessment on which the MDCG can issue comments within 60 further days. The Proposal requires the notified body to “give due consideration” to the comments received and explain how these comments have been taken into consideration for the final decision.
Companies marketing their products in Europe are quite concerned by this new mechanism. The exact scope of this mechanism is uncertain. While it only applies to Class III medical devices (i.e., the highest risk class) so far, the Commission would be empowered under the Proposal to determine specific devices other than Class III devices, to which the procedure would apply. This uncertainty is reinforced by the fact that the Proposal includes new classification rules potentially making many medical devices fall under Class III. In particular, Rule 21 of Annex II related to classification criteria would classify all devices “composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body” as Class III devices.
The industry is also very concerned that such a mechanism would in effect create more “red tape” and lead to delays in marketing new devices. There are also concerns about the effective legal protection under the scrutiny procedure. Given that the legislative process will unfold over at least a year, there will be numerous opportunities for companies to make their voices heard on aspects of the new regulatory system.