Medical Device Regulation – MDR 2017/745 Consulting Service
Our Support.
With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.
Medical devices are medical equipment and devices for in vitro tests used either in hospitals by health professionals or directly by the patient. There are over 500,000 types of medical devices and devices for in vitro tests on the EU market.
These cover a wide range of products from home-use items like sticking plasters, pregnancy tests and contact lenses to x-ray machines, pacemakers, breast implants, hip replacements and blood tests.
On 5 April 2017, 2 new Regulations on medical devices were adopted. These replace the existing Directives.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
EU MDR Timeline
2017
26 May – Entry Into Force
The EU MDR was published on 5 May 2017.
It officially entered force on 26 May 2017.
2021
26 May – Date of Application
By this date, compliance with the EU MDR became mandatory.
All medical devices and related systems had to meet the new requirements.
2022
26 May – EUDAMED and PSURs
EUDAMED was scheduled for launch.
This started a 24-month deadline for entering data into the system.
2023
26 May – PSURs for Class IIa
Periodic Safety Update Reports (PSURs) became mandatory.
This applied to all Class IIa devices.
Earlier deadlines might apply if specified in the PMS plan.
2024
26 May – Last Market Date
Certificates issued under the MDD will expire on this date.
Afterward, all devices on the market must fully comply with EU MDR.
2025
26 May – Last Service Date
This is the final date for using MDD-compliant devices.
It applies only to devices already placed on the market.
The transition period for the EU MDR began on 26 May 2017 (the date it entered into force) and ends on 26 May 2024 (the last market date for devices with unexpired MDD certificates). This provides a 7-year transition period for manufacturers to comply with the new requirements.
Key considerations for the transition period:
- Devices certified under the MDD can continue to be placed on the market until 26 May 2024, provided their certificates remain valid.
- After 26 May 2024, all devices must meet EU MDR requirements to be placed on the market.
- MDD-compliant devices already placed on the market before
May 2024 can remain in service until 26 May 2025.
IVDR Transition Timeline
The updated IVDR amendment introduces several important changes to support a smoother transition. IVDR – 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices. The IVDR transition now provides phased compliance deadlines, from 2025 to 2028, based on device risk classes to ensure a smoother shift for legacy devices.
1. Extended Transition Periods
- The transition period for legacy IVD devices is extended.
- Legacy devices are those already on the market with certificates or declarations of conformity issued before 26 May 2022.
- New deadlines depend on the risk class:
- Class D devices: Must comply by 31 December 2027.
- Class C devices: Must comply by 31 December 2028.
- Class B and Class A sterile devices: Must comply by 31 December 2029.
2. Gradual Roll-Out of EUDAMED
- Certain parts of the European Database on Medical Devices (EUDAMED) will launch earlier.
- This aims to improve transparency and access to device information.
3. Supply Interruption Notifications
- Manufacturers must notify Member States if the supply of critical medical devices or IVDs is disrupted.
The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices, which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
Some Points to keep in Mind.
The Unique Device Identification (UDI) System is intended to allow the identification and facilitate the traceability of medical devices within the distribution chain. Manufacturers must assign a single product identifier to each product; this UDI shall appear in the technical documentation, the EU declaration of conformity and on the label or the packaging of the device. The information must be shared with the UDI database and is used to report problems in the field and also should help to reduce medical errors and to fight against falsified devices.
Requirements are much more detailed regarding both content and regular updates of technical documentations and there is an increased focus on clinical assessments. Importantly, there will be no differentiation between class III documentation (MDD: design examination file) and the other classes.
According to the new rule 11 (chapter VIII) software intended to provide data used for diagnostic purposes or to make therapeutic decisions now belongs to class IIa. In certain cases the software may even be classified into IIb or III.
The acronym stands for European Database on Medical Devices. It is designed to collect information that can be shared among member states, the EU commission, notified bodies, economic operators and sponsors on marketed medical devices, conformity assessment procedures, Notified Bodies, certificates, registered economic operators, vigilance/adverse events, market surveillance and clinical investigations
The MDR has increased requirements for further and on-going clinical data before a device can be CE Marked. The amount of clinical data necessary for each device classification is proportionate to the amount of risk associated with intended use. High-risk devices such as class III and implantable medical devices will require more clinical data for approval.
The reasons behind this change.
Problems with diverging interpretation of the current Directives as well as some incidents with breast implants and metal hips highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector.
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 in vitro diagnostic 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.
- 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.
Following guidance document were issued to provide further clarity on new regulatory changes and implementation models:
- Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations
- Implementation Model for Medical Devices Regulation Step by Step Guide
- Fact Sheet for Manufacturers of Medical Devicesmd_mfr_factsheet
- Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide
- Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices
- TÜV SÜD – Fact Sheet
- MHRA -MDR – IVDR Guidance
