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Frequently Asked Questions

Market
Europe
United Kingdom
Switzerland
All
Category
Labeling
Transfer
Importation/Distribution
PRRC
In-Country Representation
Classification

An overview of the process to transfer your EU Authorized Representative (EU AR) can be found in our Knowledge Center: STEPS AND TIMING TO TRANSFER YOUR EU AR

An overview of the process to transfer your UK Responsible Person (UKRP) can be found in our Knowledge Center: STEPS AND TIMING TO TRANSFER YOUR UKRP

An overview of the process to transfer your Swiss Authorized Representative (CH-REP) can be found in our Knowledge Center: STEPS AND TIMING TO TRANSFER YOUR CH-REP

Yes, the EU Authorized Representative (EU AR) is required to be on the device labeling.

More information about what must be included and where to place the EU AR info can be found in our Knowledge Center: LABELING REQUIREMENTS FOR THE EU, UK AND SWITZERLAND IN-COUNTRY REPRESENTATIVE

Yes, the Swiss Authorized Representative (CH-REP) is required to be on the device labeling.

More information about what must be included and where to place the CH-REP info can be found in our Knowledge Center: LABELING REQUIREMENTS FOR THE EU, UK AND SWITZERLAND IN-COUNTRY REPRESENTATIVE

It depends on if the manufacturer is leveraging UKCA Marking or EU CE Marking:

  • Yes – If leveraging UKCA Marking
  • No – if leveraging EU CE Marking

More information about what must be included and where to place the UKRP info (if required) can be found in our Knowledge Center: LABELING REQUIREMENTS FOR THE EU, UK AND SWITZERLAND IN-COUNTRY REPRESENTATIVE

E-labeling for medical devices and IVDs is allowable in certain cases in the EU, UK and Switzerland.  The requirements are based on the application legislation and device type.  The applicable regulations and guidances are linked at the bottom of this FAQ.

Medical Devices

E-labeling is allowed for the following types of medical devices, if they are for professional use and use by other persons is not foreseeable:

  • Implantable and active implantable devices,
  • Fixed installed medical devices and their accessories, and
  • Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.

For all three markets, e-labeling is also permitted for professional use software products.  Further, under the updated e-labeling regulation related to the EU MDR, e-labeling is permitted for home-use software products.  The UK and EU MDD/IVDD/IVDR regulations, do not explicitly allow e-labeling for home-use software products, but in certain cases this may be justified.  Manufacturers can discuss further with their Notified Body (if applicable) or Competent Authority to confirm if it is allowable and should justify in their risk assessment that this will not impact the safe an effective use of the product with the end user.

IVDs

E-labeling is allowed for professional-use IVDs that are not specifically intended for use at point of care.*

E-labeling Requirements

Manufacturers should ensure they follow all the criteria outlined in the applicable regulation or guidance if choosing to offer e-labeling for their devices.  This generally includes, but is not limited to:

  • Conducting a risk assessment that covers the criteria included in the applicable regulation/guidance,
    • Essentially, the assessment should demonstrate that the end-user has access to and knowledge of the technology being used to provide the e-IFU, sufficient back-up to provide the IFU if the technology fails, and that the user is able to receive the IFU in paper format, if needed/requested.
  • Ensuring the e-IFU meets all the local language requirements where the product is sold,
  • Developing a process where the user can request the paper IFU at no additional cost, within the time period established by the regulation or guidance,
    • For medical devices, this is noted as 7 days whereas for IVDs the regulation just states it must be provided in a timely manner.
  • Clearly indicating when the IFUs have been revised and the ability to inform the user if the revision was necessary for safety reasons,
  • Making the e-IFU accessible to users through a website that meets the criteria in the regulation or guidance, and
  • In cases of medical devices with expiration dates, making the IFU available for the timeframes stipulated in the regulation or guidance:
    • EU MDR: For non-implantable devices – 10 years after the last device has been placed on the market and at least two years after the expiry date of the last produced medical device.  For implantable devices – 15 years after the last device has been placed on the market.
    • EU MDD/UK MD: For non-implantable devices – at least two years after the expiry date of the last produced medical device.  For implantable devices – 15 years after the last device has been placed on the market.
    • IVDs: The IVD guidance does not reference any specific timeline for keeping the IFU available for expired devices. However, the legislation imposes minimum document retention periods:
      • IVDD – 5 years after the last product has been manufactured
      • IVDR – 10 years after the last device has been placed onto the market

A full list of the criteria that must be met can be found in the regulation or guidance applicable to the market/device (linked below). 

Legislation and Guidances

  • Switzerland
    • Swissmedic has not released any information related e-labeling requirements.  However, as both the Swiss medical device (MedDO) and IVD (IvDO) regulations align with the EU MDR and IVDR respectively, and compliance with these regulations is currently required for commercializing devices in Switzerland, EU requirements for e-labeling can generally be followed in Switzerland as well.  If there is a question if these requirements apply to a specific product, manufacturers should confirm with Swissmedic directly.

*Point of Care Testing: Testing that is performed near or at the site of a patient with the result leading to a possible change in the care of a patient.

There are several factors that determine the difference between a part, a component, and an accessory. Questions the manufacturer may ask when determining if something is a spare/replacement part, a component, or an accessory are:

  • Will the item be classified in its own right?
  • Is the item a part of the finished device?

The MDR defines an accessory as an article that on its own is not a medical device; however, it is intended by the manufacturer to be used together with one or several specific medical devices to either:

  • enable the “main” finished medical device to be used in accordance with its intended purpose, or
  • assist the medical functionality of the “main” finished medical device specifically and directly in terms of its intended purpose.

Accessories for medical devices are manufactured separately from the assembled and finished device it supports, bear CE Marking, and are individually classified (separate from the “main” device) – except for accessories for active implantable devices, which are Class III.

Parts and components are terms generally used synonymously. The MDR does not define a component or a part, but they are generally an integral part of the assembled and finished medical device, and without which the finished device would not be able to function to its intended purpose. Components/parts do not bear individual CE Marking and are instead part of the finished device’s CE Marking.

A device’s parts/components may become worn or defective and need to be replaced. Replacements may be made as long as it does not adversely affect, or significantly change, the safety and performance of the device. In this case, the replacement part/component being shipped would not bear individual CE Marking. 

Yes, it is possible to send non-CE-marked medical devices to Europe for exhibition and demonstration purposes.

The requirements are to ensure that the device clearly indicates that it is:

  • Intended for presentation or demonstration purposes only, and
  • May not be made available until it is in compliance with the MDR or IVDR, as applicable.

This is allowed per MDR Article 21 and IVDR Article 19:

At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided that a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.

Yes, it is possible to send non-UKCA or non-CE Marked medical devices to the UK for exhibition and demonstration purposes.

The requirements are to ensure that there is a visible sign clearly indicating that the device cannot be marketed or put into service until it complies with the regulation. For IVD devices there is an additional requirement that “the device is not used on any specimen taken from the participants”.

This is allowed per UK MDR 2002, Part II, Section 12:

“A relevant device or a single-use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of Directive 93/42 or these Regulations.”

The citation for Active Implantable Devices is UK MDR 2002, Part III, Section 26, and for IVDs it is UK MDR 2002, Part IV, Section 39.

Yes, it is possible to send non-CE-marked medical devices to Switzerland for exhibition and demonstration purposes.

The requirements are to ensure that the device clearly indicates that it is intended solely for demonstration and presentation purposes.

This is allowed per MedDO Article 16 and IvDO Article 15:

“Products that are used exclusively for demonstration and exhibition purposes must be expressly designated as such. This notice must be clearly visible and understandable.”

A Person Responsible for Regulatory Compliance (PRRC) may be required for the EU, depending on the legislation being applied (new regulations or old directives) to the device being placed on the market.  Where required, the role is applicable to both manufacturers commercializing in the EU and EU Authorized Representatives (EU ARs). 

A PRRC is required for the manufacturer and EU AR when a device complies with the EU MDR or IVDR.  This requirement is included in Articles 15 of each regulation.

A PRRC is not required for devices conforming with the MDD, IVDD, or AIMDD, i.e., it is not required for legacy devices.  This is stated in the MDCG’s guidance documents detailing with which elements of the regulations legacy devices need to comply (medical devices: MDCG 2021-25, IVDs: MDCG 2022-8). The guidances state that Article 15 (PRRC requirements) is not applicable for MDD/IVDD/AIMDD devices.

No, a PRRC is not currently required for manufacturers commercializing in the UK nor for UK Responsible Persons (UKRPs). 

The current UK regulations (UK Medical Device Regulation 2002) are based on the old EU directives, which had not yet established the PRRC role. However, the new UK regulation is expected to introduce a role similar to the EU PRRC. The draft regulation refers to this role as a ‘Qualified Person’. A Qualified Person will be required for both the manufacturer and the UKRP.

A Person Responsible for Regulatory Compliance (PRRC) may be required for Switzerland, depending on the EU legislation being applied (new regulations or old directives) to the device being placed on the market.  Where required, the role is applicable to both manufacturers commercializing in Switzerland and Swiss Authorized Representatives (CH-REP).

A PRRC is required for the manufacturer and CH-REP when a device complies with the EU MDR or IVDR. A PRRC is not required for devices conforming with the MDD, IVDD, or AIMDD, i.e., it is not required for legacy devices.

The Swiss MedDO and IvDO establish requirements this role. For medical devices, the PRRC requirements for the manufacturer are included in MedDO Art. 49 and for CH-REP the requirements are in included in MedDO Art. 52.  For IVDs, the PRRC requirements for the manufacturer are included in IvDO Art. 42 and for CH-REP the requirements are in included in IvDO Art. 45

Both the Ordinances also reference the PRRC requirements in the MDR and IVDR (Article 15) as obligations that the PRRC must meet.  So, PRRCs complying with Swiss requires should also review and comply with the requirements for the EU regulations, in addition to what is included in the Swiss Ordinances. For example, the Swiss Ordinances also specify that both a PRRC and a deputy PRRC must be appointed.

Swissmedic specifies some additional differences between the Swiss and EU PRRC requirements in the FAQ section on their website:

Must the PRRC of a Swiss authorised representative or Swiss manufacturer be domiciled in Switzerland?

MedDO and IvDO do not define a requirement for the PRRC to be domiciled in the same jurisdiction in which the authorised representative or manufacturer is domiciled. What is relevant is that the PRRC is organisationally and professionally integrated over the long term and performs its tasks.

Can the manufacturer’s PRRC also act for the authorised representative?

MedDO and IvDO do not specify any corresponding requirements, i.e. the possibility that the PRRC of the swiss authorised representative may also be the PRRC of an EC-REP or manufacturer is not ruled out.

For both manufacturers and Authorized Representatives, the PRRC must meet one of the qualifications established in Articles 15 of the MDR/IVDR.  This applies to PRRCs in the EU and Switzerland, as the Swiss MedDO and IvDO also reference Article 15 of the MDR/IVDR when stipulating the PRRC requirements to meet.

The qualifications are:

  • A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices and/or in vitro diagnostic medical devices;
  • four years of professional experience in regulatory affairs or in quality management systems relating to medical devices and/or in vitro diagnostic medical devices.

The MDCG guidance document on the PRRC role (MDCG 2019-7) further clarifies the following two points related to the PRRC qualification requirements:

  • Any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognized by an EU Member State as equivalent to the EU corresponding qualification.
  • Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field.

Manufacturers may be able to outsource the PRRC role depending on the size and revenue of the company.

Per MDR and IVDR article 15(2), micro and small manufacturers “shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.”

Footnote 3 of the MDCG PRRC guidance (MDCG 2019-7) further clarifies that ‘micro and small manufacturers’ means entities with fewer than 50 employees and/or where the annual revenue does not exceed €10 million.  In these cases, the PRRC role can be outsourced.

If the PRRC role is outsourced, the manufacturer must demonstrate how the PRRC is permanently and continuously at the disposal of the company.  Further, the PRRC’s qualifications must be documented. Generally, this is done with a contract.

The definition of ‘placing on the market’ in the EU, UK and Switzerland can be found in our Knowledge Center: ‘PLACING ON THE MARKET’ – DEFINITION AND CUTOFF FOR EU, UK & SWITZERLAND

An overview of the differences between GMDN, EMDN and CND codes can be found in our Knowledge Center: GMDN, EMDN AND CND: WHAT IS THE DIFFERENCE?

The requirements to sell medical devices and IVDs in Northern Ireland can be found in our Knowledge Center: NORTHERN IRELAND MEDICAL DEVICE REQUIREMENTS