Our
Accreditation
We understand the need to meet the high demands and expectations of the healthcare industry. Accreditations underpin what we are as a company but also how we believe in setting high standards and maintaining them. Our accreditations are clear proof that we are committed to complying with industry regulations and laws.
Our
Accreditation
We understand the need to meet the high demands and expectations of the healthcare industry. Accreditations underpin what we are as a company but also how we believe in setting high standards and maintaining them. Our accreditations are clear proof that we are committed to complying with industry regulations and laws.
We strive to support our patients and customers while ensuring we comply with the ever-changing regulatory requirements.
The introduction of the European Medical Device Regulation 2017/745 “EU MDR” was a significant regulatory change and this was implemented on the 26th May 2017 with it becoming directly applicable on the 26th May 2021 in all EU Member States.
GenMed operates with transparency and integrity, ensuring we comply with the European Medical Device Regulations. Since the introduction of the regulations, we have taken a proactive approach in order to address the specific requirements. Furthermore, we have also met the Economic Operatore requirements we met by the date of application by re-structuring our EU supply chain.
The transition to EU MDR has to follow implementation timelines and these depend on provisions laid out within the regulation and the expiry of current certification as per the Medical Device Directive (93/42/EEC). As the regulation stipulates, this will be no later than May 2021. As a result, our customers will receive a mixture of MDD and EU MDR CE marked devices until the 25th of May 2025.
Those products marked with CE are being migrated from the Existing Medical Device Directive regulation (MDD) to EU MDR. By the end of this year, GenMed has high confidence that a high percentage of devices will be migrated to EU MDR compliance. However, this will follow a phased approach as the old MDD certificates expire.
We believe that we are in an excellent position to support our customers with innovative products that are designed to deliver improved outcomes for patients and healthcare professionals. This is down to the improved changes that the EU MDR will bring to the European regulatory framework.