Medical Device Regulation – MDR 2017 745

Information | Understanding | Best Practice.

There are a number of significant changes and additional requirements introduced into the regulation of Medical Devices within the European market due to the phasing out of the Medical Device Directives and the introduction of the Medical Device Regulation’s MDR 2017 745.
The major changes due to MDR 2017 745:

i) The Essential Requirements (ER’s) are now defined in greater detail, including the expectations placed on Technical Documentation. The ER’s are now detailed as the “General Safety and Performance Requirements”. In total there are 3 Chapters, split into 23 Sections which explain the new “General Safety and Performance Requirements. For example Chapter 1, Section 2, now demands a much greater emphasis by the Medical Device developer (manufacturer) on the need to implement Risk Management.

ii) A “Unique Device Identification” (UDI) must be applied to each medical device. The UDI will encompass both a device identifier (UDI-DI) and a production identifier (UDI-PI). The UDI label will need to be in both AIDC and HRI formats. (AIDC – Automatic Identification and Data Capture) (HRI – Human Readable Interpretation).


Medical Device Regulations MDR 2017 745

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
Etc. Etc. …
Information | Understanding | Best Practice >>>

iii) New defined roles have been established. Manufacturer’s (with an exception for small organizations) will need a “Person Responsible for Regulatory Compliance”. Also, other “economic operators” include roles such as the “Distributor”, the “EU Representative” and the “Importer”.

iv) There are new responsibilities for Eudamed (the European Medical Device Databank). Manufacturer’s will need to provide defined information to Eudamed such as the device UDI, market surveillance data (e.g. a “periodic safety update report”).

v) Clinical Evaluation and Post Market Clinical follow-up have defined requirements versus (previous) quite limited demands defined for clinical evaluation and no real requirements defined for post market clinical follow-up.

vi) Post-Market Surveillance is now extensively defined.

vii) The “conformity assessment procedures” for placing a medical device onto the market have been modified. Annex VI of the MDD is no longer an option. Also for higher risk devices (some Class IIa and most Class III devices) there are additional process steps to be followed. Notified Bodies will also need to consult expert panels.

viii) Device Classification. There is a new “classification rule 11” which is focused on software. Also, classification rules now include “active implantable” devices, “nano-materials” and “substances introduced into the body”.

ix) There is provision for the development of “Common Specifications”, which arise where the “Harmonized Standards” are insufficient or lacking in detail.

x) There are extensive new Labelling & Indications for Use requirements.



On 23 April 2020 the Council and the Parliament adopted Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions. This Regulation postpones the date of application for most Medical Devices Regulation provisions by one year – until 26 May 2021 and enters into force on the day of its publication in the Official Journal of the European Union.
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

Regulation 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions

Medical Device:

      • Validation. Classification. Regulation. Requirements. Current best practices.
      • FDA cGMP’s. EU MDR’s / MDD’s.
      • FDA Medical Device Regulation.
      • FDA Medical Device Classification.
      • EU Medical Device Regulation and Classification (per MDD’s).
      • European Medical Device Regulations (MDR’s).
      • Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
      • Quality System requirements to maintain compliant Validations.
      • Medical Device Process Validation. IQ. OQ. PQ’s.
      • Medical Device Software Validation.
      • Medical Device Design Validation.
      • Electronic Signature, Electronic Records.
      • Life Cycle Approach to Validation.
      • Risk Identification. Documentation. DHR’s. DMR’s.
      • Etc. Etc. …
      • Information | Understanding | Best Practice >>>