MEDICAL DEVICES
IN VITRO MEDICAL dEVICES
MEDICAL MOBILE APPS
CE MARKING
QUALITY ASSURANCE

Our Regulatory Affairs department is focused on medical device lifecycle compliance, including regulatory systems (EU, FDA), quality systems (ISO 13485, ISO 9001, FDA QSR), risk management (ISO 14971), product safety (IEC and ISO standards), product lifecycle testing and management, quality assurance and regulatory auditing.

Our team follows a risk-based regulatory strategy that uses regulatory compliance to fulfil the business needs in a structured way.

FREQUENTLY ASKED QUESTIONS

Covering a wide range of products, from simple bandages to the most sophisticated software, the medical devices sector plays a crucial role in the diagnosis, prevention, monitoring and treatment of diseases.​

According to Medical Device Regulation (EU) 2017/745, ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the

following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

 

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilisation of devices

‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a medical device is in conformity with the applicable requirements set out in the Regulation and other applicable Union harmonisation legislation providing for its affixing.

CE marking indicates that your product has been assessed to meet EU safety, health and environmental protection requirements and that it can be freely traded within the European Economic Area (EU + EFTA countries).

CE marking is valid for medical devices developed both inside and outside the EEA. It is required for all products, including software/apps, that fall under the definition of a medical device.

When users download and install an app with a medical purpose – diagnose, treat, monitor or prevent a disease – they expect that the software will be safe and work properly.

If your mobile health app falls under the EU definition of a medical device, it must follow a conformity assessment and bear the CE mark to be placed in the EU market. This marking assures to users, health professionals and European authorities that adequate quality, safety and performance were taken into account as per EU law.

It is very important for your company to know how your app is regulated. Market surveillance authorities throughout the entire European Union monitor products to ensure they meet all health and safety requirements as declared by the manufacturer. Regulators are putting added pressure on medical device companies to demonstrate that their technologies perform safely and as intended

Development of quality system strategies to meet regulatory and quality requirements.

Performance of gap analyses, to identify improvement measures for compliance or to improve the efficiency of business processes.

We can provide gap assessment and assistance in the preparation of quality system procedures; QA advice and support during product design & development activities (design control); management of quality system certification and inspection processes, including coordination of audits & inspections by regulatory authorities; QA training.

Design, implementation and audit of quality management systems for conformity to ISO 13485

Guidance for successful implementation of Quality Management Systems ISO 13485

Management of software development projects fully compliant with:

  • IEC 62304 – Software Development Life-Cycle Processes
  • IEC 60601 – Medical Electrical Equipment
  • IEC 62366 – Application of usability to medical devices
  • IEC 82304 – Health Software
  • IEC 80001 – Risk Management of IT networks
  • IEC/TR 80002-1 – Application of Risk Management to medical device software
  • ISO/IEC 27001 – Cybersecurity

Gap assessment and assistance in the preparation of quality system procedures.

Providing QA advice and support during product design & development activities (design control).

Management of quality system certification and inspection processes, including coordination of audits & inspections by regulatory authorities.

Providing QA advice and support in defining and implementing corrective & preventive actions (CAPA) in the case of deviations and quality improvement initiatives.

QA training.

Characterisation as a ‘medical device’ or ‘non-medical device’ is determined according to the intended purpose as defined by the manufacturer.

Intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.

Depending on the intended use of your app, it may be considered a medical device and be subject to the European Medical Device Directives / Medical Device Regulation requiring CE marking.

According to Medical Device Regulation (EU) 2017/745, ‘Authorised Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the MDR.

If your company does not have a physical location in the EU, you are required to appoint an Authorized Representative to represent your company to European Authorities. You must retain an Authorized Representative as long as you sell your medical devices in Europe.

Before placing a medical device on the European market, manufacturers need to produce Technical Documentation providing evidence of conformity with the relevant legislation.

The Medical Device Regulation (MDR) defines requirements for the Technical Documentation that has to be developed during the design and development process of a device and maintained throughout its entire life cycle.

The Technical Documentation must be kept in the premises of the manufacturer or the Authorized Representative in a clear, organized, readily searchable and available for the European Competent Authorities.

By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for compliance with the requirements of the Medical Device Regulation and all other Union legislation applicable to the device.

The EU declaration of conformity shall contain all of the following information:

  • Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
  • A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
  • The Basic UDI-DI as referred to in Part C of Annex VI;
  • Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
  • Risk class of the device in accordance with the rules set out in Annex VIII;
  • A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
  • References to any CS used and in relation to which conformity is declared;
  • Where applicable, the name and identification number of the Notified Body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
  • Where applicable, additional information;
  • Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.
INDUSTRY NEWS & UPDATES
drug_device_combination_1

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

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Amendment to the European Standard for Risk Management of Medical Devices

An European amendment to EN ISO 14971 – Medical devices – Application of risk management to medical devices, designated A11:2021, was published in December 2021, paving the way to the standard being listed in the Official Journal of the European Union (OJEU) as providing a presumption of conformity with the relevant requirements of the European Medical Device and In Vitro Diagnostics Regulations.

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risk-management

Risk Management Under EU Medical Device Regulation

Risk management is a continuous iterative process throughout the entire lifecycle of a medical device, and it requires regular systematic updating. According to EU Medical Device Regulation (EU MDR) Article 10(2), all Manufacturers are obligated to establish, document, implement and maintain a risk management system.

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Person Responsible for Regulatory Compliance (PPRC) under MDR & IVDR

The EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Device Regulation (EU IVDR) require all Manufacturers and Authorized Representatives to have a designated employee in their company who is responsible for regulatory compliance with the applicable MDR or IVDR requirements, the Person Responsible for Regulatory Compliance (PRRC).

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EUDAMED Status Update 2021

The development and deployment of EUDAMED is progressing. Following the implementation plan and getting familiar with the information stored in the database’s modules is crucial for economic operators compliance in the EU market.

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