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Address
920 Aspen Court, Boston
Clinic Hours:
9:00am – 5:00pm (Mon-Fri)
Clinic Number
(857)-200-1031
Emergencies:
(617)-350-2714
Menu
920 Aspen Court, Boston
9:00am – 5:00pm (Mon-Fri)
(857)-200-1031
(617)-350-2714
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices (MDs) in Europe, and compliance with the regulation is mandatory for MD companies that want to sell their products in the European Union. The European Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. The Regulation entered into force in May 2017 and had a staggered transitional period. The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC).
If your company was already compliant with the Medical Devices Directive (MDD), you may want to update this as the MDR represents brand new regulations with a significant number of changes. Compared with its predecessor, the MDD, the new European MDR is less focused on the pre-approval stage of medical device manufacturing, and instead, promotes a lifecycle approach to medical device regulation. While the old MDD essentially served as a manual for how medical device companies could get their CE marking and get to market, the new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for their products throughout the entire product lifecycle.
26 May 2021-25 May 2024: Certificates issued under the AIMDD/MDD before the MDR fully applies may remain valid until 25 May 2024 under certain conditions.
From May 2024: All devices placed on the market must be in conformity with the MDR.
26 May 2024-27 May 2025: MDD devices which were already placed on the market may continue to be made available
As an independent Contract Research Organization (CRO) and medical device Regulatory and Quality Consulting company, we provide full service CRO for the clinical performance studies of MDs and we consult manufacturers of MDs on the planning, preparation, execution, and reporting of performance evaluations for existing as well as novel MDs to ensure compliance with MDR. Requalite prides itself with providing the very best services for planning, writing, and documentation of evaluations and reports provisioned in MDR. We also provide resources for the manufacturers to help them navigate the system, keep current with the changes in the regulation, and train their personnel responsible for regulatory compliance.
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