Medical device standards experts and regulators discuss closer collaboration

International standards benefit both industry and regulators, agree Medical Device Symposium delegates at the IEC General Meeting

A symposium at the IEC General Meeting in Shanghai has explored the scope for closer collaboration between IEC standards developers and regulators responsible for medical devices. Participants also included conformity assessment specialists and industry experts.

Regulators symposium at the 2019 IEC General Meeting in Shanghai
Q&A session at the Regulators Symposium (Left to right: Steve Margis, seated; Scott Colburn, standing; Katharine Fraga, seated)

IEC technical committees (TCs) have been developing international standards for the safety and performance of electrical equipment used in medical practice for more than 50 years. A number of TCs carry out work covering both medical electrical equipment (MEE) and medical electrical systems (MES). Central to the process is IEC TC 62, which develops international standards and other publications for electrical equipment in medical practice.

The best known publication of TC 62, the IEC 60601 series, has become a widely accepted benchmark for medical electrical equipment around the world. IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components, ensures that the standard is properly implemented and that devices meet expectations in terms of performance, safety and reliability. IECEE certification is based on the principle of mutual recognition by its members. It plays an essential role in facilitating international trade and allowing direct access to the marketplace for vendors, retailers and buyers.

Representatives of both TC 62 and IECEE took part in the symposium. The event highlighted the benefits of maintaining a continuous dialogue between standards developers and regulators. Speakers noted, however, that for an exchange of ideas and concerns to be truly effective, it needed to start in the early stages of the standards development process.

IEC executive Katharine Fraga opened the symposium on using IEC standardization work to support medical device regulation. She underlined the important contribution made by international standards to safety, consumer confidence and global trade. Fraga described IEC standards as a valuable tool for public policymakers that contributes to harmonization of policies at the regional and international levels. She added that when IEC standards are the basis of technical regulation, companies in the regulator’s country can be more competitive at the global level too.

Scott Colburn of the US Food and Drug Administration concurred but warned that work still needed to be done to ensure that all the concerns of regulators were taken on board. Colburn was representing the International Medical Device Regulators Forum, a voluntary group of regulators from around the world.

“By and large regulators accept the use of standards,” said Colburn, “but this masks differences in degrees of acceptance.”

The remedy, he stressed, is to “communicate with regulators early and often”. Colburn suggested that early involvement gives regulators the assurance that standards developers are listening, while also helping them to develop relevant and effective regulations. In the end, he said, this made it much more likely that they would make direct use of the standard.

Colburn identified transparency as another key issue. In order for regulators to be more engaged, he pointed out, they also needed easier access to information, such as the make-up of the technical committees developing the standards. For instance, it is crucial for regulators dealing with medical devices to know how many clinicians are involved in developing the standards. Improving this kind of knowledge would boost acceptance, he concluded.

Fraga emphasized that standards provide even more value when they are combined with conformity assessment, which covers testing and certification. The IEC Conformity Assessment Systems are a framework of common rules and methodologies that ensure consistent results from anywhere in the world.

The Vice Chair of IECEE, Steve Margis, described IEC conformity assessment as a toolbox that instils trust in the marketplace. IECEE schemes test the safety, quality, efficiency and overall performance of electrical and electronic components, devices and equipment for homes, offices, workshops and health facilities, to ensure they comply with international standards. Margis said that IEC conformity assessment provided an additional guarantee to regulators because, unlike other testing and certification schemes, it is based on the principle of peer assessment.

IEC TC 62 Secretary Norbert Bischof explained the development process for standards covering electrical equipment in medical practice, diagnostic imaging equipment and equipment for radiotherapy, nuclear medicine and radiation dosimetry. Bischof stressed that from the point of view of manufacturers, national differences in regulations represent a major cost. Although one international standard for all is not possible because of specific factors such as climate, he added, the number of differences should be kept to a minimum. “International standards are not only for industry, but regulators can also benefit because they have limited resources,” Bischof concluded.

The speakers agreed that all stakeholders need to acquire knowledge about new technologies as early as possible in order to make a meaningful conversation possible. The regulators taking part in the meeting saw opportunities to use IEC work to support harmonization of regulatory requirements and showed interest in becoming more involved in standardization activities to ensure it meets their needs.