8.5 medical device regulation

Return to 2015 GA agenda page here.

Since the last General Assembly…

At the time of writing, little progress had been made in terms of completing agreement between the EU political institutions on the replacement of existing EU medical device legislation with a new Regulation (European Commission proposals from 2012 here).

EAHP’s policy statement on this topic supports strengthening of the assessment procedures for high risk devices, new UDI traceability systems and coherence in policy implementation of such traceability systems with the simarly timed implementation of the Falsified Medicines Directive’s verification system (2018).

The failure of EU national Governments to come to a unified position on reform of the medical devices directive is said to mostly be attributable to two aspects of the Directive:

1 – systems for assessment and authorisation of medical devices

Views differ between EU member states about the level of central oversight and scrutiny that is required in relation to the national based ‘notified bodies’ that currently conduct assessment and authorisation of medical devices. These notified bodies (NBs) can issue ‘CE’ marks meaning the device can be sold in all EU markets. Concern has been raised about the differing assessment standards applied by the more than 80 NBs, which could be creating opportunities for unsafe devices to enter the market.

It appears some form of compromise is emerging which will be far shy of suggestions in the European Parliament that there should be a system of central authorisation for high risk medical devices conducted by a specialised committee of the European Medicines Agency (such as takes place in the USA). Rather there may be a system of specialised notified bodies with recognised expertise in assessment of certain kinds of medical device. Device assessment could be directed to these specialised NBs via a central coordinating system.

2 – Reprocessing of single use devices

It is understood that there is also division of opinion between member states on the issue of re-processing single use devices. Some governments favour firm European guidelines and rules to prevent the reprocessing of single use devices, and others seek a more lenient regulation on this topic.

EAHP understands that completing agreement between EU member states on the matter of medical device regulation reform is a priority of the current Latvian Presidency of the Council of EU, and will be the major, possibly only, topic of the June 2015 meeting of EU health ministers.

At the meeting in Porto the EAHP Policy and Advocacy Officer will update GA delegates further about progress on the reform of medical device regulation in the EU and what it means for hospital pharmacy practice.