The MDR defines clinical evaluation as the “systematic and planned process to continuously generate, collect, analyse and assess the clinical data.” And that manufacturers shall “continuously conduct and document a clinical evaluation.”

The expectations from regulatory authorities and notified bodies are that:

• Class I device CERs should be updated when necessary (as new evidence becomes known, which may impact the clinical evaluation); however, the best practice is to update it at least every two-to-five years, depending on risk levels

• Class IIa device CERs should be updated at least every two years, or earlier when necessary

• Class IIb and III device CERs should be updated at least annually, or earlier when necessary

The above dates are not explicitly stated in the regulation. Instead, the regulation simply states that the CER should be updated throughout the life cycle of the device, i.e., through the safe and effective use period for the device, as was defined by the manufacturer in the device documentation.

So then how do manufacturers determine the appropriate timeframes to update the CER?

The short answer is that, at minimum, the CER should be updated on the same schedule as outlined in the device’s Post-Market Surveillance Plan. The reason is that:

• The MDR states that post-market surveillance data is clinical data (MDR Art. 2(48))

• The CER should be updated with any clinical data obtained from Post-Market Clinical Follow-ups* and/or from the Post-Market Surveillance Plan (MDR Art. 61(11))

• Post-Market Surveillance data should be used to update the CER (MDR Art. 83(c))

Further, a Periodic Safety Update Report (PSUR) is part of Post-Market Surveillance, and those require updates on the following schedule:

• Class IIa devices when necessary and at least every two years (MDR Art. 86(1))

• Class IIb and III devices at least annually (MDR Art. 86(1))

Since post-market surveillance data feeds into the CER, the status of the CER should be considered as post-market surveillance data is assessed. Where the post-market data shows potential new risks, this should be investigated and addressed, including in the CER. If the post-market surveillance data continues to show a positive benefit-risk ratio, this should also be noted in the CER.

The requirement for Periodic Safety Update Reports (PSUR) is throughout the device’s lifetime. Where the device is no longer being manufactured, the PSUR is expected to at least include reactive data, e.g., complaints and vigilance. And such information may warrant an update to the CER.

*Where Post-market Clinical Follow-ups (PMCFs) are required, the MDR stipulates that the PMCF evaluation report for Class III and implantable devices shall be updated at least annually (MDR Art. 61(11)(para 2).

The MDR and IVDR state that it is the manufacturer’s responsibility to translate ‘Information Supplied with the Device’, as defined by Section 23 of Annex I. This is stipulated per:

MDR Art.10(11): Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.

The question then becomes: Is the software user interface considered information supplied with the device?

The MDR and IVDR do not explicitly identify the software interface as such. Further, to date, there is no official published guidance advising one way or another.

While many notified bodies and regulatory authorities do consider the software interface as ‘information supplied with the device’, there is no single centralized position published. Therefore, manufacturers, Notified Bodies and Competent Authorities may each have differing interpretations.

Manufacturers would ideally take the following into consideration:

• Each Competent Authority has established its own translation requirements for medical devices and IVDs. The requirements may depend on if the device is for professional or layperson use. A full overview of translation requirements per market can be found on our website: HERE
  • Can you demonstrate you have met the Competent Authority’s translation requirements if the user interface is not translated into its national language?
• The MDR/IVDR Annex I, Section 23(1) states: “Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user.”
  • Is anything within the software interface potentially considered ‘safety and performance information’ that is relevant to the user?
• The MDR/IVDR’s General Safety and Performance Requirements (GSPRs) stipulate that manufacturers must “reduce risks as far as possible” and “give consideration to the technical knowledge, experience, education, training and use environment, where applicable”.
  • Can you demonstrate that you have reduced the risks as far as possible if the user interface is not translated into the user’s national language?
  • Can you demonstrate that you have sufficiently considered the user’s knowledge, experience, and education, if the user interface is not translated into the user’s national language?

Generally, if the software interface includes information required to ensure the device is used as intended and/or information related to the safety and performance, this information should be translated. This is especially important for layperson devices.

If, considering the above, a manufacturer chooses not to translate the software interface, the rationale and justification should be clearly documented in the risk assessment.  Where more definitive confirmation is needed, manufacturers should confirm directly with the local Competent Authority if it is required and/or if an exemption can be granted for their device.

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

Devices being placed on the market for the first time in the EU must be CE Marked or have been granted a derogation by an EU Competent Authority, whether they are for donation or for sale (see definition of ‘placed on the market’ in the EU here). Each EU Competent Authority can only grant a derogation for its specific market, so manufacturers must seek individual derogations for each EU country where they would like to place their product on the market without CE Marking.

Once the device has been placed on the market, it can be further resold or donated.

The MDR and IVDR only apply to medical devices being placed on the market for the first time. The EU Blue Guide 2022 clarifies that second-hand products from third countries placed on the market for the first time must comply with the EU legislation (MDR and IVDR).

There is no medical device legislation that specifically covers devices for resale or reuse, including providing devices second-hand for donation. Therefore, if a device was compliant at the time it was placed on the market, it can be further sold or donated for reuse. That being said, those further resold medical devices are still required to be safe and within their effective use period.

Devices being placed on the market for the first time in the Switzerland must meet the requirements of the applicable device Ordinance (MedDO or IvDO) or have been granted an exemption by Swissmedic, whether they are for donation or for sale (see definition of ‘placed on the market’ in Switzerland here). Information on requesting an exemption from Swissmedic can be found here.

The Swiss Ordinances only apply to medical devices being sold for the first time. And, there is no medical device legislation which specifically covers devices for resale or reuse, including providing devices second-hand for donation. Therefore, if a device was compliant at the time it was placed on the market, it can be further sold or donated for reuse. That being said, those further resold medical devices are still required to be safe and within their effective use period.

Devices being placed on the market for the first time in the UK must be CE Marked, UKCA marked, or have been granted an exemption by the MHRA, whether they are for donation or for sale (see definition of ‘placed on the market’ in the UK here). Information on requesting an exemption from the MRHA can be found here.

Once the device has been placed on the market, it can be further resold or donated.

The UK MDR 2002 only applies to medical devices being sold for the first time. And, there is no medical device legislation which specifically covers devices for resale or reuse, including providing devices second-hand for donation. Therefore, if a device was compliant at the time it was placed on the market, it can be further sold or donated for reuse.

That being said, used medical devices are still required to be safe and still need to comply with certain consumer and trade regulations. Further, the supplier of the used products should still provide certain information to the purchaser to demonstrate the safety and efficacy of the device and the device’s service history. 

More information about the specific regulations and device safety information that may be applicable is included in section 10.4 of the MHRA’s guidance document: Managing Medical Devices

The ability to sell a device in the EU with an expired CE certificate depends on the following factors:

• The applicable regulation, i.e., if the device is a ‘legacy’ product (under the MDD/IVDD/AIMDD) or certified under the MDR and IVDR; and,
• Where in the supply chain the product was when the certificate expired, i.e., if it is being ‘placed on the market’* or if it is being ‘made available’.**

‘Placed on the market’

Legacy Device (valid MDD/IVDD/AIMDD CE Certificate): Legacy devices with an expired CE Certificate are able to be ‘placed on the market’ through the below transitional deadlines, per Regulation 2023/607. This regulation came into force on 20 March 2023, automatically extending the validity of CE certificates for legacy devices.

To be eligible for these transition timelines, the device and manufacturer must meet the specific criteria established in the regulation. Read more about the requirements here.

• Class I (sterile/measuring), Class IIa, Class IIb non-implantable – 31 December 2028
• Class IIb implantable & Class III – 31 December 2027
  • (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors)

MDR/IVDR Device: MDR/IVDR devices with an expired CE Certificate cannot be ‘placed on the market’ – the CE certificate must be valid at the time the device is ‘placed on the market’.

‘Made Available on the Market’

Legacy Device (valid MDD/IVDD/AIMDD CE Certificate): Legacy Devices ‘placed on the market’ in compliance with the amended deadlines and criteria of Regulation 2023/607 may continue to be ‘made available on the market’ or ‘put into service’ without any limitation in time’ except the device’s shelf-life or expiry date (see: Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607).

MDR/IVDR Device: MDR/IVDR devices that were ‘placed on the market’ in the period where the certificate was valid and was in conformity with all applicable legislation, can further be ‘made available’ and ‘put into service’ after the CE certificate expires.

Definitions

*Placing on the Market (MDR Article 2(28)): the first making available of a device, other than an investigational device, on the Union market.

The Blue Guide further explains that devices that are manufactured (i.e. ready to ship) and have an agreement in place for purchase with a local importer are considered ‘placed on market’.  The Blue Guide further explains that ‘Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available’. Read more about the definition of ‘placing a product on the marketing’ in the EU here.

**Making available on the market (Article 2(27)): any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

***Putting into service (MDR Article 2 (29)): The stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.

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
• 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

• Europe
  • MDD: COMMISSION REGULATION (EU) No 207/2012
• • MDR: COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226
• • IVDD: MEDDEV 2.14/3 rev.1
  • IVDR: REGULATION (EU) 2017/746  (Annex I, Chapter III, Section 20.1(f))
    • In absence of a Commission Implementing Regulation to the IVDR 2017/746, manufacturers should consider the existing MEDDEV and MDR Commission Implementing Regulation for guidance.

• United Kingdom
  • Medical Devices: Guidance on the regulations for electronic instructions for use of medical devices
  • IVDs: MEDDEV 2.14/3 rev.1

• 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