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22 May 2020

Your trusted partner for orthopaedic design, manufacture, quality & regulatory

ENZTEC Regulatory Timeline web V1 col2

The regulatory and quality requirements for orthopaedic devices have become increasingly more complex and onerous over the past few years. Our customers can rest assured that Enztec remains your trusted partner of choice through:

Leading - a proud reputation as a leader for world-class devices and compliance systems.

MDR Compliant - we implement early and with confidence. Never worry about whether a product can be released into the market and have surety on your supply continuity.

Proven - our systems are proven and backed by successful audits with no findings from partners such as BSI, and many onsite audits by our customers.

Since Enztec was established in 1992, we have focussed on factors we believe differentiate us in the orthopaedic instrument market. High amongst these are:

Quality – ensuring that every part we produce is of the highest quality, and that all product and process documentation needs are met.

Regulatory - remaining current and abreast of all regulatory needs; ensuring your regulatory needs are proactively met.

As a result, we have attracted and developed a team that has a world-class understanding of these pertinent spaces, remaining at the forefront of compliance. Our Regulatory Department make a massive difference, not only to our business, but to many of our customers’ as well.

Over the last few years, there have been numerous new quality and regulatory challenges to meet. Enztec has consistently tackled each of these changes on time and without issues. We know this is critical if we are to remain a partner of choice for our customers. 

ENZTEC Regulatory Timeline web V3


ISO 13485 – Enztec was one of the first companies to obtain 13485 ahead of many of our competitors and customers.

Brexit – Enztec developed several strategies that would allow us to smoothly accommodate any Brexit scenario and ensure no disruption for our customers. As part of this, we successfully transferred from BSI UK to BSI Netherlands and onboarded a new EC Rep.

MDR – the change from MDD to MDR has been a daunting task for many in the industry. With only months left to run in the transition period, there were strong indications only 27% of companies would be MDR compliant on time. Enztec worked tirelessly to prepare for this and have since been successfully audited to MDR with no findings.

UDI-DI – the inclusion of direct part marking for all FDA classes of device comes into force in September 2020.

All new or changing requirements have placed a significant load on our internal team to not only become familiar with the requirements, but to become leaders in these areas. Our Regulatory team has achieved this in every case, executing on time and maintaining our ability to innovate and produce world-class products for our customers.

With the disruption of the COVID-19 pandemic, the European Commission decided to delay MDR implementation by one year, from 26 May 2020 to 26 May 2021.

Enztec has committed to complete our transition to have all products MDR compliant on-time per the original implementation date of 26 May 2020.

Our rationale for this MDR implementation schedule was several-fold:

  1. Early adoption – As demonstrated with ISO 13485 certification we remain committed to being ahead of the curve. By tackling the implementation now we remain a supplier our customers can trust to deliver compliant products every time.

  2. Working together –  Implementation plans are not something we can undertake alone, it is a team effort, requiring changes to labelling, part marking, procedures and more. We know it is important to get this done quickly so that we are not adding more burden to our customers as they complete their own transitions. By leading we help our customers spread their load and become a trusted supplier who delivers compliant product on time, every time.

  3. One implementation – Simply, we are implementing all MDR, Brexit, and UDI-DI changes in one smooth transition to minimise disruption to our customers, allowing them to focus on their own businesses. This also ensures our team can remain agile and get back to what they do best - producing new innovative products that make a difference for our customers.

Enztec started with a drive to be a world-class supplier of orthopaedic products, and we maintain this today – we are MDR complaint and proud of it.

If you want to know more or learn about how Enztec products and services can give you surety in this changing market, please get in touch.