EU updating legislation on medical devices manufacturing
02 May 2013
Author: Fionnuala Kilbane, marketing and communications director, Engineers Ireland
EU parliamentarians are currently considering amendments to existing EU legislation that will impact on engineers working in the medical devices industry in Ireland and across Europe.
The EU is proposing updated regulations on medical devices from over-the-counter items like sticking plasters and contact lenses to X-ray machines, pacemakers and hip replacements. Existing EU rules date back to the 1990s and have not kept pace with the enormous technological and scientific advances of the past 20 years.
Currently patients, healthcare professionals and other interested parties do not have access to essential information on how medical devices have been assessed and what clinical evidence there is to show they are safe and effective. The aim of updating the legislation is to ensure these products are safe given recent scandals in silicone breast implants and metal-on-metal hip replacements.
For manufacturers clearer rules will allow economies of scale ensuring a level playing field for all and encouraging further free trade between EU countries.
Of specific interest to Engineers Ireland is Article 13 Chapter II of the draft Regulation (2012/0266/COD). The amendment proposes to introduce a ‘qualified person’ within a manufacturer who possesses the expert knowledge in the field of medical devices.
The current amendment reads as follows:
Manufacturers shall have available within their organisations at least one qualified person who possesses expert knowledge in the field of medical devices. The expert knowledge shall be demonstrated by any of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualifications awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
(b) five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Engineers Ireland has proposed an additional clause (c) to the amendment:
(c) the national requirements for EUR ING designation, the registered professional title awarded by the European Federation of National Engineering Associations following successful assessment of competence to practice the profession of engineering in the field of medical device design or production.
Damien Owens, Engineers Ireland Registrar, explains the reason behind recommending the clause: “Engineers Ireland believes the EUR ING professional registered title offers European and national legislators the assurances they need that the ‘qualified person’ is suitably competent as the expert specified within the legislation. The title supports that the ‘qualified person’ requires both a minimum level of qualification and competence development through relevant practical experience and that the ‘qualified person’ is subject to a professional code of conduct.
“The clause expands on the educational requirements, experience and professional code of conduct required of the ‘qualified person’ and how this could be best demonstrated through professional registration. One example of this professional registration would be the achievement by the ‘qualified person’ of the national requirements for EUR ING designation, the EU-wide professional registered engineering qualification.”
Owens feels that as the standard already exists no further burden is being placed on manufacturers as the ‘qualified person’ they employ or appoint in-house only has to demonstrate his or her commitment to maintaining their competence and expertise by demonstrating their professional registration. By meeting the requirements for registration there will be a presumption of compliance with the medical device directive and no further evidence will be required. He stresses that the ‘qualified person’ should not be limited to engineers but that a similar European-wide professional registration in the pharmaceutical, scientific and medical professions may offer the same assurances. Irish Chartered Engineers are eligible to apply for the EUR ING designation.
The amendments are currently being considered by the Committee on Environment, Public Health and Food Safety and Ireland’s Mairéad McGuinness MEP is the shadow Rapporteur for the legislation. The draft report of the committee was published on 12thApril and it is due for further discussion during May.
Engineers Ireland is currently engaging with Ms. McGuinness and Ireland’s other MEPs to highlight its recommendation along with the Department of Health contact at the Permanent Representation of Ireland to the European Union. FEANI is also aware of the impending legislative changes and the opportunity to highlight further the benefits of the EUR ING standard amongst European parliamentarians.
The first and only reading of the bill is scheduled for November this year. The international guidelines will then be incorporated into EU law with the target for adoption set as 2014. The new rules will be then phased in from 2015 to 2019.http://www.engineersjournal.ie/2013/05/02/eu-updating-legislation-on-medical-devices-manufacturing/http://www.engineersjournal.ie/wp-content/uploads/2013/05/Medical_Devices.jpghttp://www.engineersjournal.ie/wp-content/uploads/2013/05/Medical_Devices-300x282.jpgBioEngineers Ireland,European Union,medical devices