27 September 2012

New proposal to revise the EU medical devices framework: what’s in it for laser equipment, contact lenses or dental implants?

Yesterday, the European Commission finally unveiled its draft proposal to revise the EU medical devices and in-vitro diagnostics framework. The proposal, which had been expected since 2008, contains 194 pages for medical devices alone.

Yesterday, the European Commission finally unveiled its draft proposal to revise the EU medical devices and in-vitro diagnostics framework. The proposal, which had been expected since 2008, contains 194 pages for medical devices alone. It will now be handed over to the European Parliament and the Council for adoption by 2014.

While the Commission was preparing the draft, Members of the European Parliament began to call for a drastic change and a pre-marketing authorisation system for high-risk devices in the wake of the PIP breast implants scandal. Upon publication of the draft proposal, the industry started to worry about the impact of the proposed scrutiny mechanism – an obligation for independent assessment bodies to notify an expert committee of new applications for conformity assessment of high-risk devices which some refer to as a “pre-marketing authorisation-like” process. The mechanism is expected to increase the time to market and uncertainty for manufacturers and to delay the access of patients to the most innovative devices: it may concern less than 50 highly innovative products a year but it would still be difficult for manufacturers to predict whether their product would fall within the mechanism or not.   

But aside from the highly debated question of the scrutiny mechanism, what does the proposal mean for manufacturers and healthcare professionals? Let alone the introduction of a unique device identifier system coupled with an extended centralised European medical devices database (accessible to the public) and increased safety, vigilance and traceability requirements, which the European industry welcomes, one aspect of the new proposal stands out: subtle changes have been made to the classification of devices with a significant impact for manufacturers and hopefully also some solutions to the long-standing problem of borderline products, those products which could potentially fall under the scope of several pieces of EU legislation (e.g. cosmetics, medical devices, medicinal products, biocides).

Non-corrective contact lenses, implants for aesthetic purposes and syringes prefilled with human collagenare now considered medical devices and manufacturers will need to comply with the conformity assessment system and regulatory requirements as set out in the new regulation. In general, products manufactured utilizing non-viable human tissues or cells and certain implantable or invasive products with aesthetic purposes that are similar to medical devices would now be considered medical devices.

There was always a thin line between medical products and drugs for those products that are “composed of substances or combinations of substances that are intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body” such as lactic acid hygienic tampons – a specific status has now been created for them: they would be classified in the highest risk class of medical devices and would also need to comply with relevant requirements of the medicinal products directive.

All devices incorporating or consisting of nanomaterial would be automatically considered part of the highest risk class unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user’s body when the device is used within its intended purpose. The majority of dental equipment would fall into the highest risk class, with cumbersome regulatory requirements, and could be subject to the scrutiny mechanism. 

The producers of software, handhelds and other devices that can be used in combination with medical devices should also beware that the accessory definition has been significantly expanded by adding the word “assist” in the definition - enable or assist the device: merely being helpful in some way might be enough for the product to be regulated as a medical device.

Finally, the classification of in-vitro diagnostics has been completely reshuffled to align with the risk-based classification model, with 4 new classes defined (in line with international regulatory guidance). However concerns have already been raisedwith clinical evidence.

On the bright side, the European Commission has already suggested an increase of its decision-making power in terms of classification which should help solve a lot of borderline cases. Previously, the classification of specific products was left to the national authorities and a number of products were classified differently from one Member State to another – although the Commission had already set an Expert Group on Borderline and Classification, the group had no mandatory power and could only propose guidelines for classification. If the new system is adopted, the Commission will have the power to determine the regulatory status of products, assisted by a group of national experts from all sectors (medical devices, in vitro diagnostics, drugs, cosmetics, biocides, human tissues and cells), using the new procedure for mandatory delegated acts.  

It will be most useful for manufacturers to assess carefully what the proposed rules mean for their products on the market and future innovations.

By Beatrice Pipitone, Consultant, Healthcare Public Affairs