#Health: Personalised medicine group helps shape new IVD rules

The European Parliament and European Council have reached a political agreement on the Medical Device Regulation and the In Vitro Medical Device Regulation.  The discussions have been ongoing since 2012.  The Brussels-based European Alliance for Personalised Medicine (EAPM) welcomes the inclusion of many suggestions and recommendations it has made during the process, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

These were formulated after numerous Alliance meetings and roundtables with key sta-keholders.  EAPM is delighted to say that it has contributed hugely to a piece of legislation that saw many amendments to the original draft as it developed and changed.

These new medical device regulations update existing EU legislation going back to the last millennium and they cover devices ranging from sticking plasters and contact lenses to breast implants and even pacemakers.

The new deal will secure further, more up-to-date, health and safety protection for patients.

The European Parliament’s shadow rapporteur, Gesine Meißner, spoke about the end result. She said: "After months of negotiation, I am very pleased that we finally found a com-promise.

"In the future, patient safety will be enhanced without any excessive bureaucratic burdens or the risk of impeding innovation. Inefficient bureaucratic procedures have been avoided,” she added.  Her fellow MEP Peter Liese was a key player in this vital piece of legislation. Liese is a member of EAPM’s STEPs group of MEPs and addressed the Alliance’s recent annual conference in Brussels.

After the political agreement, which still needs to be formally ratified, the Commission stated: “The central parts of the negotiations were, amongst others, conformity assessments, reprocessing of single-use devices, the reduction of hazardous substances or the classifi-cation of devices that contain nano-materials.

“Currently, medical devices have to pass a conformity assessment with the so called "Notified Bodies".

These Notified Bodies will be strengthened and will have to consult an expert panel on high-risk devices. Furthermore, aesthetic devices such as breast implants are now covered by the regulation,” the Commission said.  EAPM noted that the new legislative text proposes concrete mechanisms intended for the specific control of companion diagnostics, including a unique definition that should allow for their clear identification from among a milieu of 40,000 IVD products. The correct definition is a first step in acknowledging the role that companion diagnostics play in personalised health care, including their relationship to the patient and a therapy - very different from other IVDs.

To ensure the safety of patients undergoing testing with companion diagnostics, it is necessary that once analytical performance has been established, an intermediate assessment mechanism be available to ensure that patients involved in interventional studies are kept safe and that a clear path to market for companion diagnostics is not unnecessarily interrupted.

It is during these studies that companion diagnostics demonstrate their clinical validity by determining that the detected biomarker corresponds to the adequate selection of patients. The clinical validity cannot therefore be established before the study.  EAPM’s key asks on the In Vitro Diagnostic legislation were originally outlined in a ‘call to action’ document. They are as follows: Ensure patients have access to safe and reliable IVDs in a timely manner;

• define companion diagnostics appropriately to reflect the small number of IVDs that play a unique role in choosing patients that are suitable or unsuitable for a specific therapy;      Exclude special treatment for in-house assays except when no appropriate CE-marked product is available and existing loopholes are closed;
• define clear and proportional requirements for IVD devices used for ‘Distance Sales’, and;      Account for the specificities of companion diagnostics and other IVDs to ensure ap-propriate and proportionate requirements on clinical evidence, transparency, and the transition period, and;
• maintain an attractive and competitive environment for innovation in the diagnostic area, especially considering the future competitiveness of the many European SMEs developing new diagnostic test, platform and providing diagnostic servicesThe text will be voted on in a plenary of the European Parliament before the end of the year.

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