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

Our range of consultancy services covers developing and implementing regulatory strategies, managing regulatory compliance for CE marking, setting up Quality Management Systems, providing advice and support in all phases of product development, performance of audits and training.

 

  • Global regulatory strategies for medical device market access in the European Union, USA, Canada, Asia, Middle East, South and Latin America.
  • CE Marking support for all classes of mobile medical applications and medical devices.
  • Technical File/Design Dossier for CE Marking
  • Software Risk Management
  • Software Validation and Usability
  • Clinical Evaluation Report (CER)
  • Labelling and IFU compliance, translation and change control
  • Internal/supplier audits
  • Post Marketing Surveillance and Device Vigilance
  • European Authorized Representative (EAR) services
  • Guidance for implementation of Unique Device Identification (UDI)
  • Local registration liaising and support

 

 

  • Gap assessment and assistance for successful implementation of Quality Management System – EN ISO 13485
  • Providing QA advice and support during product design & development activities
  • 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.

 

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

BREXIT – Impact on Medical Devices placed in the UK market

From 31 of December 2020, the UK will be regarded as a third country and not a Member State of the European Union. There will be some changes regarding medical devices placed in the UK. The UK’s MHRA has published guidance regarding the regulation of medical devices from 1 January 2021, where it explains what changes and what there is to know about placing a medical device in the Great Britain, Northern Ireland and EU markets.

Read More »

Brazil – Class II Medical Devices – New Resolution

A new Resolution of the Collegiate Board of Directors (RDC No. 423/2020) has been published by Brazil’s National Agency of Health Surveillance (ANVISA). This new Resolution announces the elimination of the ‘Cadastro’ pathway regarding the registration of medical devices (Class II) and IVDs, substituting it with a notification registration system.

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Butylphenyl Methylpropional to be prohibited in cosmetics placed in the EU market

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. According to an amendment to the CLP Regulation (Commission Delegated Regulation No. 2020/1182), Butylphenyl Methylpropional is now classified as toxic to reproduction (Repr. 1B – CMR 1B) and it shall be prohibited in cosmetic products from 1st March 2022.

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China Bans Microbeads In Cosmetics

On 16th January 2020, China’s National Development and Reform Commission (NDRC) issued the Notice [2020] No. 80, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. More detailed information was given in the Notice [2020] No. 1146, issued by the NDRC on 10th July 2020.

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EU Medical Devices Regulation – Unique Device Identifier (UDI)

In 2017, two Regulations on medical devices (MDR) and in in vitro diagnostic medical devices (IVDR) entered into force in the European Union (EU), establishing a modernized and more robust EU legislative framework and safeguarding a better public health protection and patient safety. According to the these Regulations, the Unique Device Identifier (UDI) will be mandatory for all medical devices and in vitro medical devices.

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FDA updates on hand sanitizers safety for use

The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.

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