As it stands now, all medical devices must comply with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD). But by 2020, this will change and new medical device products distributed within Europe must comply with the new European Medical Device Regulation (MDR).
The size of the organization does not matter — EU MDR does not draw distinctions – so whether you are a large Enterprise or SME organization – you have to comply, as well as prepare for future regulations.
It has been said that Europe’s MDR is the most significant change to the regulatory framework in the medical device industry since CE Marking was introduced in 1993.
Gap analysis can be conducted by trained internal or external (consultants). The specific scope would depend on many variables (experience, classification, number of legacy devices, available/quality clinical data, compliance with state of the art). During transition, lots of guidance is not yet available, so [the] judgement of experts is critical to ensure gaps are correctly identified and addressed.
Understand the expectations and prepare the data, irrespective of whether EUDAMED is functioning to receive the data. Manufacturers must address the data requirements and have [their data] available
Implementation of the EU MDR can be complex and challenging. As you implement, it is important to understand if your plan is going in the right direction, or not.
The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:
- stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
- the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
- the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
- the introduction of a new risk classification system for medical devices in line with international guidance
- improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
- the introduction of an “implant card” containing information about implanted medical devices for a patient
- the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
- the strengthening of post-market surveillance requirements for manufacturers
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
The MDR has a transition period of three years and will fully apply from 26 May 2020.
Until now there are 5 Notified bodies designated under EU MDR
- BSI Assurance UK Ltd (NB – 0086)
- TUV SUD Product Service GmbH Zertifizierstellen (NB – 0123)
- TUV Rheinland LGA Products GmbH (NB – 0197)
- DEKRA Certification GmbH (NB – 0124)
- IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (NB – 0051)
The new regulations will ensure:
- a consistently high level of health and safety protection for EU citizens using these products
- the free and fair trade of the products throughout the EU
- that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years
We have ramped up our services and making sure we’re available to meet these really tight deadlines. Please feel free to connect and resolve your compliance gaps ahead of time.