Medical Technology Ireland 2022
Medical Technology Ireland - is Europe's second-largest medical device and manufacturing event reflecting the abundance of talent in Ireland in this important sector.
This expo and conference is Ireland's premier medical device design and manufacturing event in the beautiful city of culture and friendship – Galway! Galway is also home to our company, from where experts like Carlos Pinto are working tirelessly to provide end-to-end regulatory support to manufacturers of Medical Devices, Diagnostics and Digital Health.
This year, Carlos represented the Med-Di-Dia team and gave a presentation on Understanding the Role of Economic Operators under IVDR + MDR at the conference.
With the arrival of IVDR and MDR, the European MedTech landscape has become more vigilant and proactive towards the safety and compliance of medical devices. This proactivity poses a serious challenge to medical device manufacturers because they need to place more emphasis on Regulatory Affairs, Quality Compliance and Quality Management Systems.
MDR and IVDR are not new to the industry as the regulators had announced these regulations back in 2017, and due to COVID19, the MedTech ecosystem had ample time to plan their transition from the former IVDD/MDD to the not-so-new MDR and IVDR. Yet, many manufacturers remain unaware of the regulatory and compliance requirements. Moreover, companies still fail to understand the responsibilities and roles of different economic operators under the new regime.
In order to educate the industry about the roles and responsibilities of the various economic operators, Med-Di-Dia embraced the opportunity to take to the platform at the Medical Technology Ireland conference to provide clarification and improve understanding of this important topic.
Some key highlights from the presentation were:
Economic Operators can be easily understood by using the M.A.I.D framework
Manufacturers,
Authorised Representatives / Person Responsible for Regulatory Compliance [PRRC]
Importers
Distributors
Key Concepts for Economic Operators can be seen in the image below.
The responsibilities of PRRC have increased. All manufacturers in the European Union need to appoint a Person Responsible for Regulatory Compliance who:
- Checks the conformity of devices with QMS procedures before they are released
- Makes sure all Technical Documentation and Declarations of Conformity are up-to-date
- Ensures all post-market surveillance and reporting obligations are met
What is critical to the company is that their PRRC must always be at the company's disposal and fulfill the duties mentioned above.
Some essential articles that the manufacturers should keep in mind are highlighted in the image below.
In conclusion, manufacturers need to
- Create Appropriate Agreements
- Develop Systems and Processes
- Understand and delegate the New Regulatory Responsibility
A copy of the presentation can be requested by sending an email to mdd@mddltd.com
Med-Di-Dia is here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!
Please feel free to connect with our experts and get a FREE 30 Minute One-to-One consultation with our experts.
