The EU IVD Regulation
For more than a decade, GeneWatch UK has exposed companies making misleading claims about genetic test results (see Genes and marketing). Academics and the US Government Accountability Office (GAO) have also found many companies making misleading claims about genetic test results and people's risk of future illness. The EU's new draft IVD (In-Vitro Diagnostics) Regulation is supposed to regulate medical tests, including genetic tests. In October 2015, this Regulation entered "trialogue" (negotiations between the EU's Council, Commission and Parliament) to agree a final version of the text.
The proposed EU Regulation includes genetic tests used to predict future illness or drug response in its scope, including computer algorithms that combine multiple genetic and non-genetic factors to make personalised risk predictions. The proposed Regulation requires companies to provide information on some important characteristics of their tests, such as their predictive value. However, in the first version of the regulation, developed by the European Commission, there was no requirement for the "notified bodies" which will act as regulators to check any of this information, or to publish the evidence behind the claims. This meant that companies could use "black box" computer algorithms to predict risk without clinicians, patients or independent scientists being able to check any of their claims, making the regulation effectively meaningless. Proposed amendments made by the European Parliament's ENVI committee have since considerably improved transparency, so that summaries of evidence will have to be published, and the full dossiers will be made available on request. In September 2015, the EU Council strengthened oversight of the dossiers, although the Council's version of the text also omitted some of the improvements requested by the European Parliament.
Another proposed improvement made by the ENVI committee to the draft regulation is that tests marketed with a recommendation to take a particular drug depending on the outcome of the test (known as "companion diagnostics") will require companies to supply evidence that the combination of the test and the drug improves health outcomes. However, this proposal is not included in either the Council or the Commission versions of the text.
The proposed Regulation is an important step forward in improving oversight of genetic tests. However, it remains unclear how much scrutiny the evidence submitted by commercial companies will get before tests are placed on the market. Notified bodies will be appointed by each EU member state and companies can choose to terminate a contract with a notified body and choose another one at any time.
Although some European countries restrict Direct to Consumer (DTC) sales of genetic tests, requiring oversight by doctors, there is debate about whether or not to include similar restrictions in the Regulation.
- Press articles
- MedDeivic Online: European Parliament Adopts New Rules To Tighten IVD, Medical Device Regulation (7th April 2017)
- RAPS: EU Parliament Adopts New Medical Device, IVD Regulations (5th April 2017)
- MedTechEurope: Medical device and IVD trilogue discussions (4th May 2016)
- MedTechEurope: New Dutch Presidency enters the MD & IVD Trilogue (4th February 2016)
- Regulatory Affairs Professionals Society: As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know? (26th February 2015)
- Vox: The FDA won't let 23andMe test your genes - so it may go to Europe (12th May 2014)
- Reuters: Gene startup 23andme casts eyes abroad after U.S. regulatory hurdle (7th May 2014)
- TheParliament.com: MEPs vote for tougher controls on medical devices (27th September 2013)
- External links
- BSI: Medical device regulations clear final barrier to adoption (10th April 2017)
- Medical Devices Legal: The final text of the IVDR: first impressions (30th June 2016)
ENVI: Miscellaneous - IVD_consolidatedNegotiatedText - REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (15th June 2016)
Scroll down the agenda for a link to the text post-trilogue. The be debated by the ENVI Committee 15th-16th June 2016.
- Safer medical devices: MEPs strike deal with Council (26th May 2016)
- Council of the EU: Medical devices: deal reached on new EU rules (25th May 2016)
- EUR Lex: Procedure 2012/0267/COD COM (2012) 541: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (2012-2016)
- EU Council: Medical devices: Council mandates presidency to start talks with EP (23rd September 2015)
- Council of the EU: Latvian Presidency proposal IVD Regulation (Annexes) (12th June 2015)
- Council of the EU: Latvian Presidency proposal IVD Regulation (12th June 2015)
- ALDE: New rules on medical devices will restore patient confidence (22nd October 2013)
- S&D Group: S&Ds welcome new regulation for safer medical devices (22nd October 2013)
- EPP Group: Medical Devices: revised rules to improve patient safety and encourage innovation (22nd October 2013)
- Greens-EFA Group: Medical devices and public health MEPs vote for stricter regulation at EU level but fall short in key areas (22nd October 2013)
- Official documents
- EU: Medical devices: Council getting ready for talks with EP (19th June 2015)
- Council of the EU: Partial General Approach (12th June 2015)
EU: Revision of the medical device directives
Includes links to all documents
- Council meeting on 19 and 20 June 2014: Proposal for a Regulation of the European Parliament and of the Council on medical devices (June 2014)
- European Parliament: Medical implants: better controls and traceability to ensure patients' safety (22nd October 2013)
- European Commission: Commissioner Mimica welcomes the EP Plenary Vote on medical devices and In vitro diagnostics (22nd October 2013)
- European Parliament: In vitro diagnostic medical devices (Procedure file)
First Draft IVD Regulation
First Commission version (prior to scrutiny by MEPs)
- GeneWatch briefings