Unannounced Inspections by Notified Bodies a ‘Principal Challenge’ for 2015

By MedTech Intelligence Staff
March 26, 2015


• Categories: 05-Quality/Regulatory, RC - Medtech Regulatory Resource Center

The medical device industry in the United Kingdom has been hit hard with spending cuts by the National Health Service and decreasing prices due in part to order pooling. Also distressing to this sector is stricter EU regulation: 61 percent of businesses responding to the Maetrics study cited unannounced inspections by notified bodies as a principal challenge for 2015.

With growth stymied at home, the medical device sector is looking to emerging markets for a boost. However, more than half of survey respondents said they had concerns about regulatory compliance. In addition, some 43 percent expressed concern about finding qualified staff for such ventures.

“This is a historic and exciting time for the industry,” said Peter Rose, managing director at Maetrics. “Emerging market expansion offers an appealing solution for businesses that are feeling under pressure in mature markets, but ensuring compliance with different regulations is going to be tough.”

Additional key findings include:

• The introduction of Unique Device Identifiers (UDIs) will be one of the major challenges for 2015, especially for IT, according to 58 percent of medical device firms.
• Product launches (48 percent) and new Medical Device Regulations (45 percent) also pose significant hurdles.
• Across all UK healthcare and life science firms, respondents reveal lack of investment in compliance as businesses say they lack resources (68 percent), time (67 percent) and budget (65 percent).
• 61 percent report difficulties with implementing regulations to their specific environment.
• 60 percent say that regulations are hard to interpret and change often.

“Having a strong quality and compliance team, whether internally or externally through a consulting partner, is more important now than ever before,” Rose continued. “It’s clear that the key to fully leveraging the opportunities in emerging markets is confidence in interpreting and implementing regulations.”

The study, conducted by business analyst MindMetre, surveyed more than 50 compliance and quality management professionals from four life sciences sectors, including pharmaceutical, medical device, biotechnology and nutrition – with participants from both large corporations and small to medium enterprises (SMEs) – to determine the industry outlook, examine growth drivers and provide insight into planning and buying behaviors.