On 3 and 12 April 2013, the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) published two draft reports amending the Commission’s proposals for a Medical Devices Regulation as well for In Vitro Diagnostic Medical Devices Regulation. Now it is time to discuss more than 1000 amendments proposed by several MEPs.

EPHA is following both files and has submitted suggestions for amendments. Amongst the 145 amendments proposed by Rapporteur Dagmar Roth-Behrendt MEP (S&D, Germany), EPHA supports improvements in a number of areas including, inter alia, increased process transparency, the involvement of independent ethics committees in clinical investigations, better control over notified bodies including comparability of fees, the requirement of in-house personnel for national authorities and notified bodies, better control over subcontractors, as well as stakeholder involvement and access to relevant elements of the EU database (for patients and healthcare professionals).

Please find here an overview of the initial draft reports of both proposals for medical devices and In Vitro medical devices.

Notably, Roth-Behrendt, also called for more involvement of patients, lay persons and healthcare professionals and an expanded mandate for the European Medicines Agency (EMA).


Concerning the Scope of the Medical Devices Regulation, the Rapporteur is proposing more clarity on what health tools should be considered medical devices and into which (classification category) they should fit.

Notified Bodies

Apart from more transparency and more qualified notified bodies, the Rapporteur is calling for a more fair fees system. Roth-Behrendt believes that if those fees are made public and comparable across member states, it would avoid competition between Notified Bodies as and avoid any prejudice for patients/users.

Pre-market authorisation

The principal amendment to the Commission’s Medical Devices proposal focuses on introducing separate mechanisms for centralised and decentralised pre-market authorisation, the so-called PMA. This process would be quite similar to the US system. The Rapporteur stressed that patient safety needs to be ensured and she believes that PMA is the right process. Her proposal is controversial in the sense that centralised PMA in particular may run the risk of delays for patients in accessing vital medical devices, and there are also concerns over increased bureaucracy.

Single-use devices vs. reprocessing

Another amendment concerns single-use devices. Several amendments were drafted to ensure that single-use devices are indeed used only once. However reprocessing is accepted for some devices. The Rapporteur asks for strict rules for devices that can be reprocessed.

European databank on medical devices (EUDAMED)

As stated by MEP Roth-Behrendt the use of EUDAMED has been obligatory since 2011, although some difficulties have been expressed by the users. She proposes a more transparent system, with clear information, understandable for both the general public and healthcare professionals alike.

In Vitro medical devices

Concerning the draft report on in vitro medical devices prepared by Rapporteur Peter Liese MEP, S&D, Germany, he proposes 74 amendments of which the most relevant in terms of public health are summarised below:
- Greater testing as this is vital to proper diagnosis and treatment; "without a proper diagnostic there is no proper treatment or prevention of diseases";
- More transparency in the definition of medical devices; Explicit consideration of DNA testing and in the definition of genetic tests due to their consequences for the health of patients/consumers;
- Some devices, such as genetic tests, must entail informed consent to avoid misunderstanding and serious consequences to the health of the patient. As mentioned by the Rapporteur in amendment 30, consent shall be given explicitly in writing.
- As seen already in the medical devices report, single-use devices are under strict rules and shall not be reprocessed.
- Strict and specific rules are proposed by MEP Liese to comply with ethical principles, e.g. regarding the assessment of clinical performance studies by an independent ethics committee prior to its start, and protection of minors.
- The timelines should also be extended to allow ethics committees and authorities adequate time for reviewing applications.

However, MEP Liese does not propose a system of pre-market approval by a state authority but is in favour of continuing the current system by improving the functioning and supervision of the notified bodies. This is in line with EPHA’s current Position on Medical Devices, however members are currently reviewing the pros and cons of both options as the discussion evolves.

Next Steps:

  • 29 May 2013 - Consideration of amendments.
  • July 2013 - ENVI votes on the report

For further information:

EPHA related articles:

Last modified on June 2 2013.