The EU Medical Device Regulation (MDR) is the most significant regulatory change in Europe in over 20 years. The MDR will replace the Medical Device Directive 93/42/EEC, effective 26th May 2020. The MDR entered into force in 2017 with a three-year transition period.
There are significant changes for Medical Device manufacturers marketing their medical device in Europe. The MDR is over 175 pages and has been updated from 20 Articles to 123 Articles and contains 17 Annexes.
The new EU MDR is enforceable by law by EU member states so therefore it is essential that medical device manufactures are prepared and in compliance.
11 Key Changes to the EU Medical Device Regulation are summarised below:
Unique Device Identification (UDI) System (Article 27, Annex VI)
A UDI device identifier (UDI-DI) and a UDI production identifier (UDI-PI) will be required on all products to be placed on the EU market, with the exception of custom-made devices and investigational devices. This will allow for greater traceability and transparency of devices, improved incident reporting, improved field safety corrective actions, improved monitoring by competent authorities, reduced medical errors and fight against falsified devices reaching the market.
EUDAMED (European Database on Medical Devices) (Article 33)
EUDAMED will consist of a number of integrated electronic systems. It will be used to collect and process information relating to devices in the EU and will allow for better access and exchange of information between the public, health care professionals, notified bodies and member states.
Information will be available on the registration of devices, conformity assessments, notified bodies, certificates, economic operators, sponsors, the UDI database, clinical investigations, vigilance, market surveillance, reporting of serious adverse events, device deficiencies and updates.
EUDAMED will comply with Directive 95/46/EC and Regulation 45/2001 for the processing of personal data
Classification Rules (Annex VIII)
There are 22 classification rules in total – some of which have been updated and the inclusion of four new rules.
(Rules 1-4:Non-invasive devices, Rules 5-8:Invasive devices, Rules 9-13:Active devices, Rules 14-22:Special rules (Rules 19-22 are new rules)).
Manufacturers will need to consider these rules to determine if a device already on the market needs to be reclassified.
Rule 11: Software is one such rule where particular attention needs to be given. If manufactures have a product which contains software that has a decision making or monitoring functionality, then this will be reclassified from Class I to Class IIa. Manufactures should consult with their designated Notified Body to determine if re-classification is required.
General Safety and Performance Requirements (Annex I)
The “Essential Requirements” from the Medical Device Directive is now “General Safety and Performance Requirements”. Manufacturers will have to comply with the requirements set out in Annex I to demonstrate conformity. There are over 23 requirements, many of which are new. There is a strong emphasis on risk management and reducing risk as much as possible whilst considering the risk-benefit ratio. Manufacturers should be clear on the “Intended Purpose” of the device and consider duration of use, route of administration and materials/ substances that will be used.
Clinical Evaluation and Post-Market Clinical Follow Up (Chapter VI, Annex XIV)
Manufacturers will be required to provide sufficient clinical evidence to demonstrate conformity to the requirements set out in Annex I. A Clinical Evaluation Plan, a Clinical Evaluation Report and a Post-Market Clinical Follow Up Plan will be required. The clinical evaluation and documentation will be required to be updated throughout the product life-cycle.
For Class II b and Class III devices, manufactures may consult relevant experts to review their clinical development strategy and proposals for clinical investigation.
Clinical Investigations (Chapter VI, Annex XV)
Manufacturers will be required to implement a Clinical Investigation Plan and procedures. The Clinical Investigation Plan must be in line with the Clinical Evaluation Plan. Research methodologies used must be appropriate to the device, using the latest scientific and technical knowledge. Personnel conducting clinical investigations must be appropriately trained in both the proper use of the device and Good Clinical Practice.
Post-Market Surveillance System (Chapter VII)
Manufacturers will be required to implement a Post-Market Surveillance System as part of the QMS. Information gathered will be used to update the summary of safety and clinical performance, clinical evaluation, design and manufacturing information, benefit-risk determination, improve risk management, improve usability, performance and safety of the device and to identify needs for corrective and preventative actions.
A Periodic Safety Update Report for each product will be required. The reporting of serious incidents will be no later than 15 days.
Person Responsible for Regulatory Compliance (PRRC) (Article 15)
Manufactures will need to assign a PRRC with relevant experience in medical devices and regulatory affairs/quality management systems within their organisation. The PRRC will be responsible for ensuring the conformity of the device, technical documentation, post market surveillance and reporting obligations.
Authorised Representatives will also require a PRRC.
Risk Management (Annex I) and Quality Management System (Annex IX)
Manufacturers must establish a Risk Management system and ensure Risk Management and Risk Controls are applied throughout the life-cycle of the device. Risk Management is aligned to ISO 14971:2012.
Quality Management System requirements are aligned to ISO 13485:2016. The Post-Market Surveillance system and Clinical Evaluation Plan will form part of the QMS.
Common Specifications (Article 9)
Common Specifications will be used if harmonized standards don’t exist or are considered insufficient to demonstrate conformity in respect of the General Safety and Performance requirements (Annex I), Technical Documentation requirements (Annex II and III), Clinical Evaluation and Post-Market Clinical Follow Up (Annex XIV) and Clinical Investigations (Annex XV).
The EU Commission will implement the Common Specifications which will be developed by the Medical Device Coordination Group and relevant experts.
Monitoring of Notified Bodies (Chapter IV, Annex VII)
There will be increased monitoring and oversight of Notified Bodies (NB’s). The authority responsible for NB’s will critically evaluate the NB assessment of technical documentation, paying particular attention to Clinical Evaluation.
For Class III implantable devices and class II active devices intended to administer and/or remove a medicinal product, NB’s will be required to consult experts to evaluate their Clinical Evaluation Assessment report. This is to ensure confidence in the system and ensuring patients receive the highest level of healthcare.
Contact PharmOut to ensure you are in compliance with the EU Medical Device Regulation (EU MDR) ahead of the 26th May 2020 deadline.
Update – Delay of Implementation of EU MDR Due to Covid-19 Pandemic – May 2021
Since this blog was published in Jan 2020, the covid-19 pandemic delayed the implementation dates of the EU MDR from May 2020 to 26th May 2021.
The TGA issued a presentation on 18-May-2021 “EU Medical Device Regulation: Implications for the TGA and Australia” providing an update on the new timelines for implementation of the changes to medical device regulation in Australia.
|Reclassification of certain devices
Spinal implants, AIMDs, substances, direct contact with central circulatory system or central nervous system
|25 Aug 2020 – 25 Nov 2020|
|Medical device software||25 Aug 2020 – 25 Feb 2021|
|Personalised medical devices||25 Aug 2020 – 25 Feb 2021|
|Systems or procedure packs||25 Aug 2020 – 25 Nov 2020|
|Amendments to the Essential Principles||After commencement of EU MDR (May 2023)|
|IVD Medical Device Regulations||2 years after commencement of IVDR (May 2022)|
What are the Australian regulatory changes?
The TGA aim to align with the updated EU MDR and best practices from the FDA, IMDRF and comparable regulators
Overview of changes include:
- Align with the EU MDR requirements
- Software as a Medical Device (SaMD) classification rules
- Development of Unique Device Identifier (UDI) database
- Australian Conformity Assessment Bodies – the TGA will determine the scope of accreditation of Australian CA bodies
- Comparable to overseas regulators – TGA will allow industry to use evidence from applications from a wider range of countries to support ATRG inclusion applications
- Priority pathway for novel devices
- Review of low risk devices and other therapeutic goods
- Reforms to IVDs (companion diagnostics, self-tests)
- Development of Personalised Medical Device framework
- Enhancement to post market process (post market monitoring and surveillance)
- Reclassification of surgical meshes and other devices
- Patient materials (implant cards and information leaflets)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) is currently being updated to align with EU requirements i.e. software-based medical devices, personalised medical devices, IVD companion diagnostics and reclassification of certain devices.
The Australian Therapeutic Goods Act is being updated to include the Unique Device Identification (UDI) requirements, definitions and clarifying system or procedure pack requirements.
The Essential Principles and conformity assessment procedures are also being updated.
Mutual Recognition Agreements (MRAs)
The current MRA’s Australia has with the European Commission do not reflect the updated MDR requirements. Negotiations are ongoing between the Australian government and the European Commission regarding updates to the MRA’s.
Following Brexit and the UK departure from the EU, Australia and the UK have already signed an MRA for recognition of conformity assessment certification.
The EU are still developing guidance for the EU MDR. This may impact the updates to the Australian medical device regulations.
A copy of the TGA presentation and further information on how medical devices will be regulated in Australia can be found on the TGA website
For more blogs about medical devices, see below: