The new Medical Device Regulation, which will replace today's Medical Device Directive (MDD), is currently on its long way through the European Parliament. After a public consultation, the Committee on the Environment, Public Health and Food Safety (ENVI) must now assess around 1,000 proposed amendments (including those concerning the regulation on in-vitro diagnostic Medical Devices, which is discussed parallel to the Medical Device Regulation). In September 2013, the Committee on Internal Market and Consumer Protection (IMCO) will vote on the final draft of the MDR. It is hard to say at present which amendments to the previous draft will be included in the final document.
Chaired by Member of the European Parliament Dagmar Roth-Behrendt (who leads the European Parliament's work on the Medical Device Regulation), a hearing of the present draft of the new regulation was held before the Environment, Public Health and Food Safety Committee in February. In her report, Ms Roth-Behrendt addressed a host of issues including the much debated Premarket Approval (PMA) scheme planned by the EU, which in her opinion would delay market approval – if at all – only briefly, for a few months. However, in this context no decision has yet been made as to which "innovative" devices will have to undergo the intended PMA procedure.
This issue is now presented to the EU Commission for decision. Further critical debates are expected on provisions concerning Class III devices and their market approval by the European Medicines Agency (EMA) and on unannounced audits. The Commission's proposal was generally regarded as making good sense, with the exception of the issue concerning test processes; however, that can be clarified.
Following consultation, the EU Member States and the Internal Market and Consumer Protection Committee (IMCO) submitted more than 1,000 amendments for the MDR and In-vitro Diagnostic Medical Devices Regulation (IVD) to the responsible Environment, Public Health and Food Safety Committee (ENVI). ENVI will now review these amendments and vote on them in September. According to the Commission, 70% of the Dalli Action Plan and the associated audits have been implemented.
The MDR is slowly making its way through the legislative decision-making process and voting by the European Parliament. If voting cannot take place before the elections to the European Parliament in May 2014, a new Parliament and a new Commission would have to familiarise themselves with the subject, and delays in the introduction of the new regulation would have to be expected.
IMCO Amendments No. 88 to 212
Amendments suggested by the Internal Market and Consumer Protection Committee
The originally required Premarket Approval for high-risk devices no longer applies.
The intended obligation for Notified Bodies to notify the Medical Device Coordination Group (MDCG) of any new applications for high-risk medical devices and involve the MDCG directly in conformity assessment ("Scrutiny Procedure") will also no longer apply. Instead, the MDCG will be responsible for defining the criteria that Notified Bodies must fulfil and will further be involved in the initial qualification, notification and surveillance of Notified Bodies.
The terms "safety" and "performance" will be redefined.
An individual, company, institution, or organisation that funds a clinical investigation without actually carrying it out is also to be considered a "sponsor".
High quality and safety standards as well as guidelines for the reprocessing of single use devices are to be established at the European level.
Requirements for parts of devices consisting of more than one implantable part and the compatibility of these parts are to be included.
Refurbishment of medical devices to meet certain criteria.
The UDI system (Unique Device Identification system) is to be compatible with other existing authentication systems.
Proposal to use a single uniform language for registration in Eudamed (European Database on Medical Devices).
A summary report of safety and clinical performance for all devices classified as class III and all implantable devices is to be produced. This summary report will be complemented with data from clinical investigations and post-marketing clinical surveillance and will be validated by the Notified Body. For medical devices classified as class III, the summary report should be updated annually.
For medical devices classified as class III, proof of conformity with safety and performance requirements is to be accompanied by clinical data. Clinical investigations will also become indispensable for new devices.
Data of adverse events and safety-related data may not be considered commercially sensitive information.