PARIS — As of the first of the month, the newly revised European directives regulating medical devices have begun being adopted by the 27 EU member states and then progressively will be implemented in those countries.
Full enforcement of the directives will become effective in 2010.
As of the end of July, the revised directives approved by the European Parliament were adopted by the Council of the European Union and are now being translated into all languages required for publication in the Official Journal of Europe.
The directives affect more than 10,000 types of products covering the range of medical applications from prosthetics to implants, from surgical devices to wound care, and including software for those devices.
With the revision to the original 1993 directives, Europe is passing a milestone in what has been a long journey toward harmonizing the diverse laws regulating medical devices in a highly fragmented but lucrative market that covers some 450 million citizens.
The journey never ends, of course.
“To make things even more confusing, the Commission is already working on major revisions to the revised directives,” said Anna Ludwinek, public affairs executive with the European medical device industry association Eucomed (Brussels, Belgium).
She told Diagnostics & Imaging Week that the European Commission this month will formally begin to address a host of issues resulting from the development of emerging technologies and new materials, for example, the thorny problem of single-use devices, or advanced therapies, such as hybrid drug/device products, that were excluded.
The approved directives winding their way into law include the overarching Medical Device Directive, (MDD 93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EC), the In-Vitro Diagnostic Devices Directive (IVDD, 98/79/EC) and the Personal Protective Equipment Directive (PPE 89/686/EEC).
All but the Personal Protective Equipment Directive are called “new approach” directives that aim to harmonize rules to allow the free circulation of medical devices in the EU.
Products that fall within their scope must be CE-marked to show that they comply and must meet all applicable essential safety and administrative requirements. Qualifying products may be freely sold throughout the European Economic Area (EEA) without being subject to additional national legislation, except in matters concerning funding and reimbursement.
The much-compromised and amended directives were passed overwhelmingly, with 645 representatives for the proposal and only 15 against. Passage was assured by a compromise reached in early March with the European Council on product labeling, reprocessing and greater transparency.
Reproccesing refers to single-use products, which has caused so much disagreement (as it has in the U.S.) It has taken three years to bring these revisions to Parliament.
In August, the EC closed a web-based dialogue exploring suggestions for better handling of reprocessed medical devices addressed in Article 12a of the revised Directive 93/42/EEC. The commission is now assessing responses to the central questionnaire.
The European Association for Medical Device Reprocessing (EAMDR; Brussels), which seeks clear and binding conditions for decontamination practices in Europe, said the resolution adopted “was less concrete than had been hoped for.
“Nonetheless, by adopting the directive the European Parliament has acknowledged just how important is this topic,” the association said in a letter to members, saying, rather optimistically, “The European Commission is obliged to submit a report on medical device decontamination within the next three years and to explore whether further proposals are needed.”
The newly-passed regulation leaves decisions and policies on device reprocessing to individual member states.
Germany is one of the few European countries to allow medical device decontamination, regardless of the device’s designation, and a sizable industry has emerged that, based on nearly five years experience, is ready to expand to other opportunities as European countries loosen regulations.
German reprocessing companies report that after testing more than 20,000 products, some 16% of all single-use labeled medical devices may be reprocessed under the country’s strict guidelines.
EAMDR estimates overall revenues of the European disinfection and sterilization equipment market will expand to $708 million by 2011, or about 26%.
Getinge (Getinge, Sweden), the MMM Group (M nchener Medizin Mechanik, Munich, Germany), Belimed (Munich), Matachana (Barcelona, Spain), Cisa (Torri di Quartesolo, Italy) and Aesculap (Tuttlingen, Germany), part of the B. Braun Melsungen group (Melsungen, Germany), have developed a strong European presence due to the base business in Germany, according to EAMDR.
The emerging potential for hybrid products that mix pharmaceuticals, biotechnologies and medical devices also were not addressed by the revised directives. The EC said it will fold such regulations into legislation for advanced therapy medicinal products that is being developed.
Eucomed objects to this approach, saying that current regulations for hybrid products “have worked well so far.”
Eucomed cites drug-eluting stents as an example, saying, “These devices were made rapidly available to patients in the EU, thanks to the existing regulatory framework,” that establishes the quality and safety of the medicinal substance in parallel with the applicable requirements of the Medicinal Products Directive.
The new directives also open the door for harmonizing e-labeling of medical devices in Europe.
Device labeling in the previous EU directives refer only to “leaflets,” but the new requirements would allow a CD-ROM or downloadable PDF documents, as well as information available on a screen built into a device, for example the pacemaker monitor cited above.
Eucomed threw its support behind the changes, saying, “With more than 20 different EU languages, the size and volume of the paper instructions for use are considerable, and electronic support can also be more easily updated and disseminated.”