MDR certified for Class Ir, Im and IIa Devices

11 November 2020

Enztec is MDR certified for Class Ir, Im and IIa Devices 

Enztec has just achieved an enviable milestone – one which looks set to boost New Zealand’s export earnings and create new jobs in the face of current Covid-19 economic uncertainty.

Enztec is among the first manufacturers of orthopaedic surgical devices worldwide to be awarded highly-sought-after Medical Device Regulation (MDR) certification. Certification of its Class Ir, Im and IIa devices allows Enztec to continue to place its products in the European (EU) and other lucrative markets which leverage the CE mark, ahead of most of its global competitors.

“We are thrilled to achieve MDR certification,” says Enztec Chief Executive Iain McMillan. “Gaining this approval was a mammoth, time-consuming task and our success is an absolute testament to the skills and capabilities of our team. It creates an extraordinary opportunity for us to ramp up supply of our orthopaedic surgical instruments and to get a jump-start on our competitors in the next one to two years. We can continue to offer our customers a complete solution which includes regulatory compliance in Europe and beyond”.

McMillan says Enztec began the application process last year. “We saw this as an opportunity to capitalise on the disruption we knew this change in regulation would cause in the market”. He says meeting the exacting standards of the European Commission to gain approval has been an arduous but ultimately rewarding process. “We have followed this with investment in new machinery and people, actively re-training existing staff as well as recruiting and bringing in new employees to help us meet the strict certification requirements”.

“We’ve worked tirelessly, putting in around 15,000 hours of time to transition our systems and products to achieve certification” says McMillan. ”We made use of the Covid-19 lockdown period to task our staff with MDR-related activities and its really paid off. A significant number of our international competitors, including billion dollar companies, are not yet MDR certified, with market reports suggesting many will fail to achieve this by next May’s deadline. Some have been forced to pull staff from product development to now focus on gaining compliance while others are actually withdrawing their products. This is a golden opportunity for us to grow our market share further”.

Iain McMillan says MDR certification will not only allow the business to thrive but expand – and that will require employing more people to fill roles in design, manufacturing and regulatory.

“It’s exciting that a company like ours from Christchurch, New Zealand can achieve such success in the international health tech space” says McMillan. “As a city, Christchurch really bats above its weight in terms of developing and manufacturing medical devices and technologies which are making a huge splash internationally.  Here at Enztec, MDR certification means not only can we now grow the business further and provide certainty for our customers, but give confidence to patients worldwide that they’ll have the best possible outcomes when surgeons use our products”. 

Written by: Lorelei Mason

Back to articles