The submission of the PM1 Pachymeter for CE marking represents a critical milestone in launching the PM1 in European markets. The CE mark is a conformity mark that indicates compliance with health, safety, and environmental protection standards within the European Economic Area (EEA), and we are proud to be en route to meeting these rigorous standards.
To achieve this important milestone, Occuity chose Kiwa Dare B.V. as our approved Notified Body. Our submission involved two critical elements. The first is our quality management system, which has been successfully audited to ISO13485:2016 for the design, manufacture, sales, packaging and distribution of Ophthalmic instruments. The second element is the PM1’s technical file, which includes the historical evidence, build records and compliance traceability that is necessary to ensure that a new product is both safe and fulfils a clear clinical need.
The submission documents were created with input from a large number of the Occuity team, however, extra recognition must be given to Head of Operations, Sharon Branch, for leading the project, and Ben Tomlinson, who was the final reviewer and responsible for the final submission. As an experienced EU MDR Quality Engineer, Ben's knowledge proved vital in ensuring that Occuity complied with all the necessary regulations and requirements.
Another component of the submission was the clinical evaluation report, which both provides proof that the meter makes the measurement with the required precision and accuracy and includes a usability study which shows how the PM1 Pachymeter meets the needs of clinicians and patients. The above elements, alongside a risk file, technical file, and all supporting documentation such as drawings, designs, and verification proofs, are crucial to the final CE submission.
On this development, Occuity CEO and Co-founder, Dan Daly said, "We are excited to have achieved this significant milestone and are very proud of the hard work and dedication of our team. The submission is now in the hands of our Notified Body and we are just awaiting the final approval then we can start to sell the PM1 Pachymeter."
Sharon Branch, Head of Operations, further commented:
"We see this achievement as a testament to our team's commitment to delivering the highest quality product while complying with all necessary regulations and standards. We are confident in our strong position and eagerly anticipate the opportunity to sell our PM1 Pachymeter in European markets once we receive the CE mark certification."
The PM1 Pachymeter is a groundbreaking device that uses Occuity's patented technology to measure the thickness of the cornea, a crucial element in the diagnosis of eye diseases such as glaucoma and keratoconus. Unlike traditional methods, the PM1 Pachymeter is non-invasive, painless, and can be performed in a matter of seconds.