Updated: EU Reaches Agreement on New Medical Device, IVD Regulations

Posted 25 May 2016 | By Zachary Brennan 

Updated: EU Reaches Agreement on New Medical Device, IVD Regulations

The EU late Wednesday finally reached an agreement on updates to the overarching regulations for medical devices and in vitro diagnostics that haven’t been updated since the 1990s.

The agreed to draft regulations, the texts of which were not released, are expected to ensure that medical devices and in vitro diagnostics are safe and that patients can benefit from them in a timely manner.

The political agreement between the Netherlands presidency of the European Council and representatives of the European Parliament is still subject to the approval by the Council's Permanent Representatives Committee and the Parliament's Committee on Environment, Public Health and Food Safety (ENVI).

“This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients' health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25,000 medical devices manufacturers in the EU, many of which are SMEs [small and medium-sized companies] and which employ more than half a million persons," said Edith Schippers, Minister of Health of the Netherlands and President of the Council.

Disagreement and arguments over the new regulations have gone on since 2014.

Jérôme Unterhuber, spokesman for the Council of the European Union, told Focus two of the sticking points holding up the negotiations dealt with the reprocessing of devices meant for single use and genetic tests.

"The NL Presidency of the Council and the representatives of the EP [European Parliament] agreed that reprocessing and further use of such devices will only be possible where it is explicitly authorised by national law and will be subject to strict rules ensuring safety. For reprocessed single-use devices all the responsibilities of the original manufacturer go over to the reprocessor. The EP had originally asked to allow reprocessing of single-use medical devices unless it is banned by member states," Unterhuber told us. 

And as far as genetic tests, he said, "The EP had asked that where a genetic test is used for instance to diagnose the predisposition of diseases member states must provide the tested person with relevant information on the significance and the implications of the genetic test. Since the organistion of the health system is a national competence the Council (which, as you may know, represents the 28 member states) was not able to accept this demand. At the end the 2 co-legislators agreed that member states provide this kind of information 'as appropriate.'"

Gert Bos, executive director and partner at the device consultancy Qserve Group, told Focus that other sticking points in the negotiations were related to notified body supervision, increased scrutiny on the premarket assessment of devices, reprotoxic substances and transitioning mechanisms.

And as far as the notified bodies are concerned, Bos wrote on his blog Thursday morning: "Although already a massive Joint Assessment program has started to clean house in the much criticized notified bodies, resulting in a significant reduction of these third party assessment bodies, the new legislation will force all of them to reapply and be evaluated from scratch."

Industry trade group MedTech Europe added in a statement Thursday: "Entering the implementation phase, it is critical that the large volume of secondary legislation transfers this complex framework into feasible and implementable rules, whilst avoiding unnecessary bureaucracy for all involved parties. The industry will continue to work together with legislators and other stakeholders to achieve this objective."

New Regulations

The agreement announced Wednesday is expected to tighten the regulation and surveillance of notified bodies, the independent entities responsible for assessing medical devices before they can be marketed.

The new regulations will also give notified bodies the right to carry out unannounced device manufacturing facility inspections and such bodies will have to ensure that they have qualified personnel.

In addition, the draft regulations, which were first released in 2012, establish how manufacturers will be responsible for tracking the quality, performance and safety of devices.

Manufacturers and other economic operators will have clear responsibilities in terms of liability, but also on registering complaints on devices. The draft regulations also improve the availability of clinical data on devices and strengthen the protection of patients participating in device trials.

Also included is a proposal to create a Medical Device Coordination Group comprised of national representatives that will double check assessments of high-risk devices carried out by notified bodies before the devices are placed on the market. 

The new EU rules also explicitly cover certain devices without a medical purpose but with similar characteristics as medical devices, including fillers and colored contact lenses.


In addition to the new notified body and manufacturer requirements, a new central database will be created to track economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates.

Under the current system, it’s not always possible to establish what companies produced devices sold in the EU, and what clinical evidence was used to determine they are safe and effective. Several member states have set up electronic registration tools. However, these tools are not always compatible with each other, making traceability across borders difficult.

The new database, however, will offer patients, healthcare professionals and the public with comprehensive information on products available in the EU. Devices will have a unique identification number, like the unique device identifier, to provide for traceability throughout the supply chain to the end-user or patient.  

What’s to Come

The Council's Permanent Representatives Committee will be invited to endorse the agreement probably in mid-June 2016, according to Parliament.

Once Parliament's ENVI committee has also confirmed that it can accept the compromise, the Council will be invited to confirm the agreement. Following the revision of the texts by the lawyer-linguists, the two regulations will have to be formally adopted by the Council and the Parliament. The new rules will apply three years after publication for medical devices and five years after publication for in vitro diagnostics. 

Editor's Note: This article was updated on 5/26/16 with comment from the Council and experts.

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