With a certificate, the question of competence becomes clear

By getting certified, you get proof of your competence, something that MTF encourages its members to do. By increasing your knowledge within MDR, you will pass the test that will be required to certify you with MTF's sister association, RAPS. One of MTF's members helped to validate the questions for the exam.

MTF's committed member Lucy Robertshaw has just returned from a trip to Holland, where she spent two days validating questions for an exam that will be given to those who want to become certified within the medical device regulation (MDR) Medical Device regulation. The certificate in the production due to Article 15 "Person responsible for regulatory compliance" and the person who receives it must meet the criteria "required competence in the field of medical devices through a diploma or 4 years of professional experience in regulatory matters or in quality management systems related to medical devices."

Read more about Lucy Robertshaw MTF member

Certificate of knowledge - a matter of the heart

To easily ensure the right competence and authorization in the right place is something that Lucy is passionate about. She suffers with the industry and the companies that are forced to shut down promising development projects. This applies to medical technology products that are ready for the user and that could save the lives of patients but that fall on the finish line.

- All too often it is seemingly small mistakes that topple the whole project, says Lucy. Even though the product is in the final phase and close to launch with all the time and money invested, there may be a couple of signatures at the beginning of the work that are missing.

Validated questions and answers

At the beginning of the month (8-9 May 2023), Lucy was invited to validate the questions in the RAPS certification test for MDR. Together with a group of other regulatory experts, questions and answers were linked to paragraphs and letters in the regulatory framework. The result will hopefully be launched this autumn and means that people who work with medical technology issues can become certified within the MDR.

- Of course I recommend everyone who works with medical technology products to get certified and it is an absolute must for every company in the industry to have at least one certified person, says Lucy.

Difficult to find training in time

Lucy, who herself works with issues in quality and regulatory compliance, searched for a long time for training to prepare for the new regulatory framework, MDR. Although she was out in good time, it was difficult to find courses in Sweden, so Lucy is mostly self-taught. The regulations came into effect two years ago, in May 2021, and despite that, many uncertainties remain. There is a lack of both competence to adapt activities and resources at the accreditation bodies.

- There are few or no companies that have the resources to queue at the accreditation bodies. This means that the launch will be postponed, a couple of three years at worst, explains Lucy.

MTF courses

MTF works to increase knowledge in the field and with its collective knowledge and experience has produced material for courses in both MDR and IVDR. There are no dates for open courses today, but they are given on request.

Read more about MTF's training courses

Why should I get certified?

The advantages of certification are several, in addition to the actual competence development that you acquire through training, a certificate means professional credibility, greater career opportunities, professional development, networking opportunities and increased competitiveness. Lucy advises:

- A certificate is the easiest way to demonstrate your competence, an easy-to-understand and visual proof that you have the necessary expertise, provided it is issued by a recognized organization.

MTF encourages certification

The purpose of MTF's association activities is to promote the status and scientific development of the professional field, to contribute to better conditions for research and to maintain a high level of medical technology activities in healthcare and industry. Among other things, by offering training and certification.

At MTF, you can apply for certification in medical technology at three different levels:

• Medical civil engineer/technical master

• Medical engineer/Bachelor's degree

• Medical technology base level

Read more about MTF's certifications

About RAPS

RAPS, which stands for Regulatory Affairs Professionals Society, is a global professional organization that promotes the development and professionalization of regulatory affairs professionals in the healthcare industry.

Read more on the RAPS website

About MDR

The MDR is the Medical Device Regulation and is a set of regulations that harmonizes requirements for the development, manufacture and marketing of medical devices within the European Union (EU). The aim is to increase the security of the user. The Swedish Medicines Agency is the supervisory authority.

Read more about MDR on the Swedish Medicines Agency's website MDR at Swedish Medicines Agency

Photo: Lucy Robertshaw, DALL-E, Pixabay
Text: This article is compiled as a collaboration Carolinn Olsson and Lucy Robertshaw