Medical Device Regulation
The Medical Device Regulation 2017/745 (MDR)
In May 2017, important changes were made to the medical device legislation of the European Union. After years of work, two new regulations (direct European laws) came into force:
- Medical Device Regulation 2017/745 (MDR)
- Invitro Diagnostic Device Regulation 2017/746 (IVDR)
They gradually replace the three existing directives:
- 93/42/EEC (Medical Device Directive, MDD)
- 90/385/EEC (Active Implantable Medical Devices, AIMD)
- 89/79/EC (Invitro Diagnostic Device Regulation, IVD)
The aim of the new EU-wide and uniform regulations is to ensure patient safety and to enhance the quality of medical devices on the European market for the benefit of all.
The Medical Device Regulation 2017/745 (MDR) already came into force on 25 May 2017, but the legislator granted a three-year transition period, which was extended by one year due to the corona pandemic. All economic operators must comply with the regulation by 26 May 2021, with some exceptions. The requirements of the MDR, e.g. that manufacturers have a complete MDR-compliant technical documentation of their medical devices, must be met by this date.
Manufacturers in particular are facing major challenges, as the implementation of the new requirements involves high effort and costs. The extent to which the changes arising from those regulatory replacement affects your business depends on the role you hold.
This website focuses on the new Medical Device Regulation 2017/745 (MDR) and serves primarily as a source of information for manufacturers of custom-made devices, a significant role of patient care providers.
Since 1993, the Directive (EU) 93/42/EEC on medical devices (MDD) has been in place and implemented in the national laws of the affected countries.
On 26 May 2017, the Regulation (EU) 2017/745 on medical devices (MDR) came into force; the transition period has been defined for three years. Due to the coronavirus pandemic, it was extended for one year, and the new Medical Device Regulation will be fully applicable in May 2021.
Main changes compared with MDD
The number of articles and annexes has increased massively with the introduction of the MDR. However, this has enabled improvements in the production and supply of medical devices, which was absolutely necessary.
There is one major difference between the MDD and the new MDR at the operational level: Every EU member state implemented the Medical Device Directive (MDD) in their individual national laws. In contrast to this, the MDR does not have to be broken down into local laws, but is already the valid regulation for all EU nations.
Main changes regarding the content:
- Labeling requirements have been massively increased.
- Clinical investigations and evaluations are regulated according to more than 20 articles.
- A unique device identification (UDI) will be required.
- A "person responsible for regulatory compliance (PRRC)" must be appointed.
- The EUDAMED database will be extended:
- Access to competent authorities, manufacturers, notified bodies and the public
- Display of certificates, vigilance reports, clinical investigations and PMCFs
- Improved transparency through a comprehensive EU database on medical devices and a device traceability system based on unique device identification
- Reinforcement of the rules on clinical evidence
- Strengthening of post-market surveillance
- Optimised coordination mechanisms between EU countries in the fields of vigilance and market surveillance
- Reinforcement of the criteria for designation and processes for oversight of notified bodies
Relevant annexes for patient care providers
It is not possible to give a general answer to which annexes of the MDR are valid for patient care providers. It always depends on which economic operator role is taken. For manufacturers of custom-made devices, there are three annexes that are described here in detail. If you manufacture serial devices, there are additional relevant annexes.
Annex I "General Safety and Performance Requirement"
The General Safety and Performance Requirements outline the level of safety that every medical device on the EU market needs to fulfil. They are structured in three chapters:
|I. General requirements||Outlines the requirements for a compliant risk management system.|
|II. Requirements regarding design and manufacture||Outlines requirements that need to be considered in the design and manufacture of a device, e.g.|
|III. Requirements regarding the information supplied with the device||Outlines requirements regarding the content of labels and instructions for use|
Annex XIII "Procedure for custom-made devices"
Annex XIII describes the main requirements that need to be fulfilled to place a custom-made device on the market and contains 5 sections:
- Requires manufacturers of custom-made devices to draw up a statement for each device containing a defined set of information.
- Requires manufacturers of custom-made devices to draw up and keep up to date a documentation to show compliance with the MDR.
- Requires manufacturers of custom-made devices to document the manufacturing activities including other manufacturing sites (e.g. iFab).
- Requires manufactures of custom-made devices to store the documentation and statement for a period of at least 10 years (15 for implanted devices).
- Requires manufacturers of custom-made medical devices to perform post-market surveillance activities for the devices placed on the market.
Annex XIV "Clinical Evaluation and Post-Market Clinical Follow-Up"
Annex XIV outlines how a clinical evaluation has to be performed and which tasks need to be done for a post-market clinical follow-up (PMCF). The annex is therefore divided into two parts:
Part A Clinical Evaluation:
- Specifies that a clinical evaluation needs to be planned
- Specifies the content of a clinical evaluation plan and report
- Requires the results of the clinical evaluation to be included in a report
Part B Post-Market clinical follow-up
- Specifies content of PMCF documentation
- Can be justified for not being applicable