Major steps and support for acquiring the CE Marking on a Medical Device or Diagnostic
Overview of the Regulatory Process for Manufacturers of Medical Devices and In-Vitro Diagnostics
In the European Union, medical devices and in-vitro diagnostics must complete a conformity assessment to demonstrate that they comply with EU regulations and that product quality, performance and safety are ensured. Before placing a product on the market, manufacturers must issue a Declaration of Conformity and the product needs to be CE marked.
The steps below outline the basic regulatory process for innovators aiming to develop and market medical devices or in-vitro diagnostics in the European Union.
1. Define the intended purpose and classify the product as a medical device/ in-vitro diagnostic
Define the intended use of the product, as this will be decisive for its classification, and not the functionality of the product itself.
Classification of the product as a medical device, in-vitro diagnostic or not, must be made according to the definitions provided in the EU regulations on medical devices and in-vitro diagnostics (MDR, 2017/745 and IVDR, 2017/746).
The national competent authorities, or a Notified Body, can give guidance on the correct classification of medical devices or in-vitro diagnostics. In Portugal, the national competent authority is INFARMED which can also provide guidance on product classification 0.
For more information on the definitions and regulations of medical devices and in-vitro diagnostics refer to The Basis for Regulation of Medical Devices in Portugal component of this chapter.
Regulatory pathways vary for health technologies and in the case of medical devices, they also vary depending on their classification that is linked to the level of associated risk. Before classification the manufacture needs to evaluate whether its product is effectively a medical device. If the product as a medical purpose the analysis can be done through the scheme below (each point of decision in the scheme it is based on scientific data).
Medical Devices make borderlines with medicines, cosmetic, personal hygiene products, biocides, software, and individual protection equipment. That is why sometimes is difficult to qualify and classify a product.
For example, Vaseline is an example of a product that can acquire several classifications: if your target end is the lubrication of probes used in medical diagnosis, it should be classified as a medical device. On the other hand, if used as a laxative, it is considered to be a medicinal product. It could also be considered a cosmetic and personal hygiene product if used as a healthy skin emollient.
2. Determine which EU regulation and Portuguese laws apply to your product and determine the risk classification
Determine the relevant EU regulation (MDR, 2017/745 or IVDR, 2017/746) that defines the regulatory requirements for placing your product on the market. Additional requirements, specific to Portugal should also be assessed or discussed with regulatory specialists.
Classify your product according to the risk class in Annex VIII of the MDR, or in Annex VIII of the IVDR.
The risk classification of the product defines what conformity assessment procedures can be followed, and whether the conformity assessment must involve a Notified Body 0, 0.
For more information on the risk-based classification of medical devices and in-vitro diagnostics refer to the European Union Wide Market Authorisation component of this chapter.
Innovators need to understand the classification system based on risk when developing a robust regulatory strategy.
3. Appoint a regulatory compliance officer and establish a quality management system (if applicable to your product)
Appoint a “Regulatory Compliance Officer” in your organisation who is responsible for compliance with the various regulatory requirements. You must be able to prove that this person is appropriately qualified 0, 0.
Implement a Quality Management System (QMS), depending on the risk class of your product. Compliance with QMS requirements is usually certified according to ISO 13485, which provides a practical foundation to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices and in-vitro diagnostics.
The validity of the quality management system according to ISO 13485 will be examined by external auditors (e.g. Notified Bodies) and needs to be reviewed every year. It typically takes between six and nine months between the start of QMS establishment and audit/ certification. Often the availability of Notified Bodies is an issue and should be considered during the planning stage.
For more information on Quality Management Systems and ISO standards refer to the Regulatory Requirements for Marketing Authorisation component of this chapter.
4. Develop the product in compliance with regulatory requirements and prepare the technical documentation, including supporting evidence
Develop your product in compliance with processes defined by your QM system. In parallel, develop the technical documentation according to Annex II and III of the MDR (2017/745) or IVDR (2017/746), respectively, to demonstrate compliance with regulatory requirements (e.g. General Safety and Performance Requirements, harmonised standards and common specifications) as well as QM system during the conformity assessment.
Prepare a clinical evaluation plan or performance evaluation plan on how to generate the evidence required to demonstrate the safety and performance of your product and seek the required authorisation from competent authorities (e.g. INFARMED) to conduct the planned clinical investigations or performance evaluations.
For more information on technical documentation and regulatory requirements (e.g. clinical evidence) for conformity assessment refer to the Regulatory Requirements for Marketing Authorisation component of this chapter.
5. Pass a conformity assessment (if applicable to your product), prepare a Declaration of Conformity and place a CE mark on the product
Have your QM system and the product’s technical documentation audited for its compliance with regulatory requirements by a Notified Body (not required for uncritical products such as most class 1 medical devices and class A in-vitro diagnostics) and obtain CE marking certificate for your product and ISO 13485 certificates for your facility.
CE marking certificates are valid for a maximum of five years but are typically reviewed during an annual surveillance audit. With the new regulations, timelines for conformity assessment are expected to increase significantly over the 3-9 month experienced under the old EU directives, especially during the transition period for the new medical device and in-vitro diagnostics regulations.
Please note that for high-risk products additional stakeholders, such competent authorities, expert panels and reference laboratories, might be involved to assess the product’s safety and performance, likely extending the duration of the assessment procedure further 0, 0, 0.
Prepare a Declaration of Conformity, which states that the product complies with the applicable regulatory requirements and place a CE (Conformité Européenne) mark on the product (according to Annex IV and V of the MDR (2017/745) or IVDR (2017/746)) 0, 0, 0.
For more information on conformity assessment, declaration of conformity and CE marking refer to the European Union Wide Marketing Authorisation component of this chapter.
6. Register and place your product on the EU market, and start post-market surveillance
Register the product and its Unique Device Identifier (UDI) in the EUDAMED database. If you are not located in the European Union, you should also have an “Authorised Representative” located in the European Union who is qualified to handle regulatory issues 0.
Place the product on the market, ensure ongoing compliance with regulatory requirements, including post-market surveillance, will be assessed annually by a Notified Body. Failure to pass the audit will invalidate their CE Marking certificate. Annual audits, as well as the audit to renew your CE marking certificate will need to be carefully planned ahead of time 0.
SME Support and Initiatives
INFARMED scientific advice process
INFARMED created guidance for the Regulatory and Scientific Advice (RSA) to help applicants – RSA is provided by INFARMED through the Regulatory and Scientific Advice Office (GARC). The objective of this document helps applicants to submit products in accordance with the current regulatory and scientific requirements 0.
“The Regulatory and Scientific Advice Office has the competence to advise on issues arising with the preparation of documentation for:
- A clinical trial, marketing authorisation, submission of variations, renewals or other subjects related to medicines for human use;
- EC marking or complementary procedures;
- notification or registration of medical devices and cosmetic products;
- licensing and good practices procedures” 0.
Innovators should use all available services and individuals with expertise and experience to increase chances of success.
SMEs should leverage the possibility of seeking scientific advice from INFARMED to allow for an early understanding of medical device or in-vitro diagnostic qualification and classification as well as of regulatory requirements specific for their products in development to be marketed in Portugal.
As new regulations are being introduced, establishing and maintaining the relevant regulatory expertise and providing the necessary financial, time and personnel resources can be a challenge, especially for SMEs. Funding support for SMEs along the process from research to marketing provides important opportunities that should be leveraged and factored into the business plan.
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