Before continuing with the focus on the product, one needs to consider the company or companies that will be developing, potentially producing and ultimately commercialising this product.
The expertise required by developers of medical devices is significant. In addition to the general design and engineering expertise which is required of any industrial products company. Medical device developers also require risk management, quality management, medical and regulatory compliance expertise. Read through Article 10 and consider whether your company has or can recruit the expertise needed to develop and gain approval for a medical device? Does it also have the capabilities to manufacturer, distribute and support the intended users in multiple countries? Consider whether some or maybe even all of these activities should be sub-contracted to specialists.
Deliverables for demonstrating compliance:
(1) The Design and Manufacturing processes (Art. 10, 1),
(2) The Risk Management process (Article 10, 2),
(3) The Clinical Evaluation process (Article 10, 3),
(4) The processes for development and maintenance of technical documentation, UDI and the EU declaration of conformity (Article 10, 4-8),
(5) The Quality Management System (Article 10, 9),
(6) The Post Market Surveillance planning process (Article 10, 10),
(7) The labelling development process, including producing language translations (Article 10, 11),
(8) The corrective action and recall process (Article 10, 12),
(9) The vigilance process, including reporting of serious incidents and field safety corrective actions (Article 10, 13),
(10) The regulatory authority interaction process (Article 10, 14),
(11) The legal liability and damage compensation process (Article 10, 16),
(12) One or more persons overseeing the regulatory compliance (Article 15),
(13) Access to technical, safety (risk), clinical, quality and regulatory expertise.
Guidance
Guidance is also available from the Medical Device Coordination Group;
on clinical evaluation - go to Step 4: Complete the clinical evaluation.
on unique device identification (UDI):
- MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
- MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system.
- MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.
- MDCG 2021-09 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers.
- MDCG 2018-1 Rev. 4 Guidance on basic UDI-DI and changes to UDI-DI.
- MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers.
- MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017.
- MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI.
- MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database.
- MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16.
- MDCG 2018-5 UDI assignment to medical device software.
- MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs.
- MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs.
on post market surveillance (PMS) and vigilance
- MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template.
- MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices.
- MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745.
on person responsible for regulatory compliance (PRRC)
- MDCG 2019-7 - Rev.1 Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC).
Hi All,
Can you please advise. How many stability batches shall be tested to support the change of manufacture?
In this process you describe, the application of harmonised standards is not mentioned. Am I missing something?
If they exist, harmonised standards should be followed, but in the area of resource management processes there is a limited number of standards. Often MDCG of IMDRF guidance will be the main source. However, if you read on to Step 3 you will certainly find harmonised standards mentioned as they are the primary basis for compliance in the product technical area.
How or why would a distributor of raw materials would be even requested to fill out an EU MDR Compliance Report?
We supply raw stock titanium with all the proper material certifications and such and do not manufacture or produce any finished or even semi-finished goods. Nothing we provide to our customers would be available for sale on any market.
If your company is not one of the following; a manufacturer of finished medical devices, an authorised representative of such a manufacturer, an importer of medical devices into the EU/EEA or a distributor of medical devices within the EU/EEA, then it is unlikely the EU MDR could apply to your company.
Thank you for several explanations regarding the MDR on your website.
Several FAQ’s are dealing with “legacy devices” during the “grace period”, mentioned in art. 120(3). Explained is that only MDR art. 5 is derogated, except PMS, MS, vigilance and registration. Other MDR articles apply after DoA (i.e. 26 may 2021), such as: art. 11 (AR), art. 13 (Importer), art. 14 (Distributor).
How are the obligations of manufacturers regarding legal devices during the legacy period in art. 10, for example: section 9: quality management system; section 16: liability coverage? Further is a PRRC required for the manufacturer and the authorised representative?
The minimum requirement, in addition to continuing to comply with the legacy Directive, is to additionally fulfil the registration, vigilance and PMS processes of the EU MDR. No other requirements from the EU MDR are mandated for those who are following Art 120(3), but nothing is prohibited. It is a business decision.
Why is it necessary to write a procedure for say Clinical Evaluation when the process/procedure is essentially spelled out in the MEDDEV guidance document and the MDR? Same is true for the Vigilance procedure. the guidance essentially outlines the procedure you follow and in most cases you are just copying the same procedure and putting it in your own format.
Any thoughts?
Thank you for your question.
Manufacturer’s are required to have a quality management system and EU ISO 13485 is the quality management system model recognised by EU competent authorities and notified bodies. ISO 13485 requires manufacturers have “control of documents”, including “documentation specified by applicable regulatory requirements”.
Each manufacturer is free to decide the manner in which it controls documents and the format of its procedures. However, most quality professionals will advise that maintaining references to external documents is particularly problematic, as changes to such documents are by definition outside of the manufacturer’s control.
What is meant by point 13? (13) Access to technical, safety (risk), clinical, quality and regulatory expertise.
Thank you for your question
As stated above. Medical device developers require risk management, quality management, medical and regulatory compliance expertise. Potential medical device developers should consider whether they already have or can recruit the expertise needed, or whether some or even all activities should be sub-contracted to specialists.