Regulatory Affairs News
Get the latest news on medical device regulation
Swissmedic
Updated FSCA form (MU680_21_019, v.2.3), with the following changes:
- On page 1: added field to indicate the expected date of the next FSCA report.
- On page 5: grouped all options for actions to be taken on the same page (in the previous version, the option âNoneâ was not readily visible).
- On page 6: improved the buttons to add and remove sub-actions.
- On page 7: in the list of countries affected, separated CH and LI, for clarity.
- On page 7: added the following line to the final statement âthe FSN to be published complies with data protection regulationsâ (see below information on data protection).
Communication sent by Swissmedic to Swiss economic operators via e-mail on 25-Apr-2024 requesting that, for data protection purposes, Field Safety Notices (FSN) do not include:
- Personal data (e.g. names, personalized e-mail addresses, personal telephone numbers, signatures, etc.). Instead, generic e-mail addresses (e.g. info@company.com) or generic contact details (e.g. customer service) should be used.
- Customersâ details.
Swiss MedTech
Guidance on placing of âlegacyâ devices on the Swiss market after 26 May 2024 published on 25-Apr-2024. Intended for Swiss importers, distributors, and manufacturers, the guideline helps clarify that âlegacyâ devices CE-marked under the MDD/AIMDD that will not be transitioning to the EU MDR, can no longer be âplaced on the marketâ after 26 May 2024. It also provides details on the risks for certain specific cases, like consignment warehouses or MDSW made available via online web shops.
Swissmedic
Overhauled Swissmedicâs information sheet on Medical Device Software, significantly expanded from the previous version with:
- Important new section on Class I medical device software (MDSW), outlining possible MDSW functionality that would classify as Class I under the Swiss MedDO. This represents a shift in Swissmedicâs traditionally conservative approach to MDSW and places Swissmedicâs interpretation ahead of the expected review of EUâs MDCG 2019-11 planned for late 2024.
- Regulatory requirements in terms of General Safety & Performance Requirements (GSPRs), technical documentation, clinical/performance evaluation, and labelling & UDI, in alignment with the EU MDR/IVDR.
- Brief references to MDSW distance sales, economic operators obligations, and post-market obligations.
- Updated and clearer references to the legal framework in Switzerland, also pointing to EU legislation, MDCG guidelines, and potentially applicable standards.
European Commission
New MDCG documents published:
MDCG 2022-9 rev.1 Summary of Safety Performance template (for IVDs) update Rev. 1
- Clarification on when the SSP should be made available to patients
MDCG 2024-4 Safety reporting in performance studies (for IVDs)
- Reporting obligations of the sponsor due to adverse events
- Reporting method, types of events, and pathways
MDCG 2024-5 Investigatorâs Brochure contents for clinical investigations
- Guidance provided on topics covered in EU MDR Annex XV, section 2.7
- Appendix A – cross-referencing Annex XV is separately published as Word doc.
European Commission
A Study and a dashboard on the reprocessing and reuse of single-use-devices in the EU have been published:
- Study on the implementation of Article 17 of EU MDR in the EU
- The Dashboard – presents an overview of the mapping activities
SCHEER
The preliminary update of SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices has been published for public consultation. It describes:
- the evaluation of possible alternatives for phthalates used in medical devices, including alternative materials, designs, or medical treatments,
- the methodology for performing a benefit-risk assessment, justifying keeping the presence of CMR and endocrine-disrupting phthalates at percentages above 0.1% w/w.
Swissmedic
New version of Guidance document for Export Certificates with minor clarification amendment to section 4.6.2 on Devices according to applicable legislation
EU-CH negotiations
Last week the Swiss Federal Council signed off the mandate to resume negotiations with the European Union on bilateral agreement. You can read more about this here:
Although it is not stated clearly, these negotiations aim to reach an agreement by the end of 2024. We estimate that the mandate may take 2-3 more years to be agreed or even disregarded, as Swiss politics are known to be extremely cautious and, even if there is a majority in the Swiss parliament, the proposed mandate will be subject to referendum. Our take from the resumed bilateral negotiations is that the requirement to appoint a SAR/CH-REP will be maintained at least in the mid-term.
European Commission
MDCG just published its MDCG guidance development plan for 2024
- Amongst the new, long-awaited documents: updated Vigilance forms, extended guidance on PMS and Vigilance for IVDs, guidance on IVD borderline issues and even RUO (Research Use Only), and guidance on Master UDI-DI.
- Also, extensive work on documents for notified bodies is expected in Q2 2024.
- And, for software, a âtargeted revisionâ of MDCG 2019-11 (relative to medical device software qualification and classification), FAQs on the interrelation of EU MDR/IVDR and the new AI Act, as well as new guidance on the legal status of app providers, all three due by Q4 2024, sound promising.
European Commission
Published updates to Harmonised Standards (HS):
- Implementing Decision (EU) 2024/815 on HS under the EU MDR with updates to:
- EN 455-3:2023 (on single-use gloves),
- EN ISO 10993-15:2023, EN ISO 10993-17:2023 and EN ISO 10993-18:2020 (on biological evaluation),
- EN ISO 11137-2:2015, EN ISO 11607-1:2020, and EN ISO 11607-2:2020 (relevant for sterilized devices),
- EN ISO 17664-2:2023 (on reprocessing).
- The consolidated HS list is now also available: Summary list EU MDR
- Implementing Decision (EU) 2024/817 on HS under the IVDR with updates to:
- EN ISO 11137-2:2015, EN ISO 11607-1:2020, and EN ISO 11607-2:2020 (relevant for sterilized IVDs)
- The consolidated HS list is now also available: Summary list IVDR
MDCG 2024-3: Clinical Investigation Plan
- Details provided about the content of the CIP
- The template of CIP synopsis is provided in the Appendix
This MDCG guidance document was already generically referenced in revision 1 of MDCG 2021-6 issued in December 2023. Another generic reference concerns an MDCG guidance document on the Investigatorâs Brochure, which is expected to be published soon.
Updates to the dashboard for Notified Body survey on certification and application (EU MDR/IVDR)
- Average timeframe to sign a written agreement: 62% take less than 2 months
- Time to reach a new Certificate: QMS 6-12 months, QMS + Product 13-18 months
European Parliament
Artificial Intelligence Act adopted as Regulation on 13-Mar-2024:
- European Parliament officially approved the AI Act
- is now subject to final lawyer-linguist check
- will enter into force 20 days after its publication in the Official Journal, and be fully applicable 24 months after it enters into force
MedTech Europe
Position paper regarding the Industry perspective on the final AI Act published on 13-Mar-2024. Main requests:
- Timely EC guidelines for the applicability of the AI Act to the medical technology sector, involving also key stakeholders (i.e. MDCG)
- Support for the single conformity assessment and technical documentation
- Clear pathway for clinical/performance evaluation. They express the concern that CE marking under the AI Regulation would be required before investigational devices or IVDs for performance studies can be used in pre-market studies under the EU MDR or IVDR.
Proposal for âOne Substance, One Assessmentâ package published on 14-Mar-2024. Main aspects:
- Concept of âOne Substance, One Assessmentâ
- Propose optimizing the package of legislations for OSOA
- Consider the new role of ECHA, clarify the interface between REACH and RoHS (preventing regulatory overlaps)
IMDRF
IMDRF Adverse Event Terminology (AET) codes have a new release in February 2024, including:
- Annex A: Added 6 new terms and modified 4 terms.
- Annex B: No change
- Annex C: Added 1 new term.
- Annex D: Added 2 new terms and modified 2 terms.
- Annex E: Added 46 new terms and modified 12 terms and retired 1 term
- Annex F: Added 5 new terms and modified 1 term.
- Annex G: Added 1 new term and modified 1 term.
Swissmedic
Switzerland-Liechtenstein collaboration in medical device surveillance
Swissmedic and the Office for Health of the principality of Liechtenstein signed a new agreement regulating collaboration on clinical investigations, medical devices, and in vitro diagnostic medical device surveillance in the Customs Treaty area (Switzerland/Liechtenstein economic area)
Swissmedic
Information sheet on CAPA for Economic Operators
- Intended to support economic operators of medical devices in the development of CAPA plans to address Swissmedicâs findings during inspections, based on the Demingâs cycle (Plan-Do-Check-Act).
- Swissmedic reminds economic operators that they must proactively identify deviations from legal requirements at all times, independently of the market surveillance by authorities.
Team NB
Position paper on Classification of SARS-Cov-2
- Under MDCG 2020-16 (currently, rev. 2 of February 2023), IVDs for SARS-CoV-2 correspond to Class D IVDs, per Rule 1 in IVDR Annex VIII.
- Team-NB considers that the current level of risks associated with COVID, which are lower than during the pandemic, warrants a reclassification:
- Recommended Class C, per Rule 3c
- Potential further reclassification to Class B, per Rule 6, once more data on the post-pandemic phase, especially regarding the long COVID syndrome, are available.
- This Team-NB position paper is expected to trigger another review of MDCG 2020-16.
European Commission
Second call for EU reference laboratories for high-risk IVDs
- The EU Commission is considering launching a second call for applicants because no EU reference labs could be designated for the remaining 4 categories of Class D IVDs (arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping).
- Interested laboratories are invited to informally express interest to their Member State by 30 April 2024.
EU Council endorses the proposed EU MDR & IVDR amendments
- EU Parliament and Council shall be adopting the amendment to the EU MDR and IVDR.
- Final text for the amending Regulation agreed: 2024/0021(COD).
US FDA
US FDA aligns QMSR with ISO 13485:2016
- On January 31st, US FDA published the final rule amending cGMP (current Good Manufacturing Practice) in their Quality Management System Regulations (QMSR) to align more closely with ISO 13485:2016: the Quality Management System Regulation (QMSR) Final Rule.
- This was an expected and significant step forward in international alignment.
EUDAMED
EUDAMED User Guide and templates v. 2.14 updated:
- Certificate and SSCP/SSP information can be found in Basic UDI-DI section.
- Bugs fixed
- Newly added functions related to registering SSCP/SSP and linking Basic UDI-DI
- Hyperlink of Basic UDI-DI from NB & Certificate module to UDI/Device module will be automatically updated
- Indication the validation of the new SSCP/SSP master document is required (NBâs obligation)
- Bugs fixed
- Include the information on inactivation of the SSCP/SSP and related certificates in the payload when downloading.
- Bugs fixed
EU Health Technology Assessment (HTA)
Updated rolling plan for the implementation of Reg. (EU) 2021/2282 on HTA published on 6-Feb-2024.
Fifth information stakeholder event planned for 09-Apr-2024: From Theory to Practice – Implementing the EU HTA Regulation
Video recordings of the stakeholder event held on 30-Jan-2024 available from the event webpage: From Theory to Practice – Implementing the EU HTA Regulation
Topics discussed:
- Understanding key elements of the EU HTA Regulation
- Challenges and opportunities in the implementation process
- Involving stakeholders in EU HTA implementation
European Commission
MDCG 2024-2 Procedures for the updates of the EMDN:
- The Nomenclature Working Group (NOM WG) is responsible for the use of EMDN
- Annual revisions of the EMDN – 4 phases throughout the year
- Expedited review for ad-hoc updates of the EMDN
- platform for EMDN requests (visualization of existing EMDN codes less user-friendly than in previous website version)
Swissmedic
New timelines for swissdamed release:
- Actor (ACT) module for registration of economic operators – 2nd half of 2024 (instead of 1Q2024)
- UDI module to register devices – available 4 months after the ACT moduleâs go-live
Notified Body
BSI FAQs on EU MDR transition (new version)
- Clarification on renewal of the old certificates, NBâs confirmation letters, NB transfers due to MDR transition, changes to âlegacy devicesâ
- Clarification of MDR application with BSI
Notified Bodies Survey on certifications and applications – Status Oct. 2023
- Update status by October 2023
- All NB surveys presented in The Dashboard
COCIR
Joint statement in support of the extension of e-IFU for medical devices (2-Feb-2024)
- Proposal for an update to the scope of Reg. (EU) 2021/2226 for specific product categories
- Highlights advantages of e-IFU for professional use
European Commission
Published MDCGs for Device Specific Vigilance Guidances Templates:
- A general explanation of the report criteria for serious incidence, PSR, and Trend Report
- Guidance for reporting and IMDRF codes
MDCG 2024-1 Device Specific Vigilance Guidances (DSVG) Template
- MDCG 2024-1-1 DSVG 01 Devices for Cardiac Ablation
- MDCG 2024-1-2 DSVG 02 Coronary Stents and associated delivery systems
- MDCG 2024-1-3 DSVG 03 Cardiac Implantable Electronic Devices
- MDCG 2024-1-4 DSVG 04 Breast Implants
Swissmedic
Published checklist (available only in German and French) in support of the Swiss Guideline for the validation and routine monitoring of cleaning and disinfection processes for medical devices, intended as an aid for healthcare professionals who check the annual validation reports of instrument washer disinfectors and trolley washer-disinfectors.
European Commission
Draft amendment to EU MDR and IVDR via Commission proposal for extended transition periods for legacy IVDs, early EUDAMED deployment and mandatory notification of device supply interruption:
- New obligations for manufacturers to notify the relevant competent authorities, economic operators, and healthcare institutions/professionals of critical discontinuation of medical devices and IVDs. Concerned economic operators having received such notification shall forward it further down the distribution chain.
- Early mandatory use of already available EUDAMED modules – Q4/2025
- New transition periods for legacy IVDs
- Class D IVDs 31 December 2027
- Class C IVDs 31 December 2028
- Class A sterile and Class B IVDs 31 December 2029
Medtech Europe
Reaction to EC proposal to extend transition periods for IVDR
- Acknowledges and supports any measures that keep devices available to the patients
- Points out 4 important conditions to be met before EUDAMED modules are made mandatory (see joint open letter below)
- Proposes that notification of critical device discontinuation should be as simple as possible
Joint open letter: In anticipation of EUDAMED availability for mandatory use
- Listed the four preconditions to be med before EUDAMED would be made mandatory
- National Databases should be phased out in favor of EUDAMED
- Central and single sources of truth
Swissmedic
Published meeting notes for Roundtable on Medical Technology (RTMT) held on 11-Nov-2023
- Swissdamed:
- the Actor Module go-live in Q1/2024
- product registration is planned for the summer 2024
- Swiss Medtech – pointed out the differences in the need for the authorized representative for Procedure Packs and Systems in Switzerland vs. EU
- Swiss Medtech – provided further feedback on FSC, incident reporting, manufacturerâs self-declaration, and introduced new problems (e.g. non-recognition of Turkish Notified Body)
Swissmedic
New section on swissdamed: Questions and Answers
- General questions and answers on registration information of CHRN, deadlines, and language-related questions
- Some registration guidance questions but still no release of swissdamed
European Commission
Overview of national language requirements in EEA/Turkey for manufacturers of medical devices and IVDs:Â Language Requirements Table MDRÂ and Language Requirements Table IVDR. Information in both tables about languages required at a national level for:
- Relevant national legal provisions
- Label/IFU
- Implant card
- DoC
- FSN
- Documents for conformity assessment
- GUI (Graphic user interface)
A new version of the Joint implementation and preparedness plan for IVDR
- General updates on contents related to MDCG guidelines
- General updates on the status of actions
- Newly added:
- EURLs high priority action 3.7
- Guidance for NBs high priority action 5.5, 5.6 & 5.7
- Performance evaluation and expert panels action 6.5 & 6.6
- Section 12 – âOrphanâ device and action 12.1
Swissmedic
- Layout renew
- New contact detail
Information and assessment of CH-REP regarding the former notified body ECM
- Targeted check â selected a sample of 15 SAR for assessment
- 8 SAR do not have manufacturers with ECM certificates
- 7 SAR do have manufacturers with ECM certificates. But no suitable measures had been taken by the SAR.
- Swissmedic is ordering corrective measures for such SAR
European Commission
- Presents an overview of the data gathered from different stakeholders
- Integrate comparable data from previous surveys of NBs conducted by the EC
Swissmedic
New organisational structure with separate Medical Devices Surveillance Sector
- Responsible for: safety of clinical trials, Vigilance (called âMateriovigilanceâ), and market monitoring of medical devices.
- Also responsible for monitoring the maintenance and processing of medical devices in hospitals
Swiss legislation (new version 01.01.2024):
- Federal Act on Therapeutic Products, TPA (SR 812.21): New Art. 14 §3 on labelling simplification plans for parallel imports of pharmaceuticals.
- Data Protection Ordinance, DPO (SR 235.11):Â Updated Art. 41 to replace the name âNational Center for Cybersecurity (NSCS)â by âFederal Office of Cybersecurityâ.
- Federal Act on Chemicals, ChemA (SR 813.1):Â New Art. 10a and Art. 25a relative to biocides
- Ordinance on Reducing Risks of Chemicals, OChRR (SR 814.81):Â The updates are part of the bi-annual reviews of restrictions on chemical substances (the reviews are published in January and June).
- Waste Ordinance, ADWO (SR 814.600): Updated Art. 15 §3 on recycling of phosphorus, per the updated OChRR.
Swissmedic
Information Sheet: Clinical investigations with medical devices rev. 4.3
- New references are added in Appendix A7 on in-house manufacturing in healthcare institutions.
- Update on sending CIOMS forms for SUSAR (suspected unexpected serious adverse reactions) to Swissmedic in Appendix A7.
Information Sheet: Performance studies with IVD rev. 3.4
- New references are added in Appendix A7 on in-house manufacturing.
- Update on sending CIOMS forms for SUSAR (suspected unexpected serious adverse reactions) to Swissmedic in Appendix A7.
European Commission
MDCG 2021-17 Rev. 1 on importers and distributors:
- Clarification of the fact that the same entity cannot be both the importer and distributor of a given device
- Clarification on the accompanying document that indicated importer details
- Clarification on Procedure Pack or System Producer endorses an additional importer or distributor role if the producer is not the manufacturer of devices brought together
MDCG 2019-7 Rev. 1 on PRRC, provides clarifications for:
- Demonstration of the evidence of qualification of the PRRC
- The availability requirement of the PRRC (no need to be 24-hour available)
- PRRC related to Art. 16(1) on the entity that repackages the devices
- PRRC related to the entity reprocessing the single-use device
- PRRC related to Art. 22(4) on Procedure Pack and Systems Producer
- Table 1 of criteria for exemption from clinical investigations for implantable and Class III
- Flowchart of consideration for (4) cases listed in Appendix I
- Hierarchy of levels of access to the data to be considered for the demonstration of equivalence is listed in Table 2 in Appendix II
Team NB
NBâs Position Paper on Medical Device Lifetime:
- Expectation and guidance documents of MD Lifetime
- Consideration of different devices:
- Active devices
- Software devices
- Implantable devices
- Biological devices
- Clinica data expected
- Statistical analysis
- Team-NBâs recommendations
Swissmedic
Frequently Asked Questions updates on Devices manufactured and used in healthcare institutions, new section added:
- In-house IVD (according to IvDO)
- Requirements according to Art. 5 Abs. 5 Bst. a-i EU IVDR
- General Information for In-house IVDs
- Further Obligations of healthcare institutions (vigilance, maintenance, cybersecurity, microbiological laboratories)
Information Sheet on Derogation:
- Lists further data to be submitted as part of a derogation request.
- The number of devices placed on the market in the last three years, the expected number of derogated products to be placed on the market, and the list of intended customers are now also required.
Product groups without an intended medical purpose page update:
- Video explaining what are Annex XVI products
- Video of transitional provisions in Switzerland and the legal requirements
European Commission
MDCG 2021-6 Rev.1 – MDR Clinical investigations: More guidance by adding new questions and Annex III.
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products
- Clarifications for qualification of accessories, dual-purpose devices, multiple intended purpose devices
- Pratical issues of qualification are provided
- Examples of products out of scope of Annex XVI products
- Classification examples for 6 groups of devices
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: Clarification for the application of the clinical criterion to products w/o a medical purpose
BSI: Regulation of MD and IVD in Northern Ireland
- MDR and IVDR apply in Northern Ireland, the MHRA (the Medicines and Healthcare Products Regulatory Authority) is the de facto Competent Authority for Northern Ireland.
- No requirement for an NI manufacturer to appoint a UK RP or EU AR.
- EU CE-marked devices can be sold in NI
- GB-based manufacturers need EU AR or NI-based AR to sell devices in NI
Swiss Medtech: Guidance on regulatory requirements for optical frames
- Guidance on distributor, importer, manufacturer
- Examples for maintenance and repair
- Regulatory requirements for maintenance and repair
- QMS for opticians
- Checklist to review the packaging and documents
European Commission
The designated EURLs together cover the following categories of class D IVDs:
- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
The EURLs are expected to take up their tasks in the conformity assessment of devices on 1 October 2024.
Five EURLs have been designated.
MedTech Europe/COCIR
- MedTech Europe and COCIR are partnering to present a joint medical technology industry perspective on the final agreement of the Data Act.
- There are no substantial changes.
Swissmedic
BW690_00_001defi_FO Orders for export certificates for medical devices
- New form version (v.1.3) for ordering of export certificates (Free Sales Certificates, FSC)
- Watermark protection when uncompleted forms
- No substantial changes
European Union
Reg. (EU) 2023/2482 amending REACH â Amendments to Regulation (EC) No 1907/2006 concerning bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Changes of Article 1 with the following definitions:
- 1 January 2029 as âLatest application dateâ
- 1 July 2030 as the âSunset dateâ, placing on the market and the use of the substance prohibited.
MedTech Europe
Position paper – The Future of Europeâs Medical Technology Regulations
Ensuring efficiency, for example:
- Considerably cut down on unnecessary bureaucracy in conformity assessment
- Put in place a âpay for procedureâ model
- Fully digitise the EU system
- Permit digital labelling
- More differentiation should be made between IVD class B and class C professional laboratory devices
- Remove the limited validity of certificates
Embracing innovation, for example:
- Early / pre-filing / pre-market dialogues
- Create dedicated and accelerated assessment pathways
- Improve the EU emergency use pathways
- Adopt âpre-certificationâ access models
- Adopt evidence requirements
- Consider where devices can be brought through the European CE-marking system more quickly, based on regulatory
- decisions taken by other jurisdictions
Effective governance, for example:
- Taking system-level decisions
- Driving a healthy ecosystem for medical technologies
- Managing the decentralised network of Notified Bodies
- Authoring guidance documents
- Representing the system both within Europe and globally
- Creating a structured, on-going stakeholder dialogue mechanism to identify needs for adapting the system
The Swiss Ordinances on Medical Devices (MedDO, SR 812.213) and on In-vitro Diagnostics (IvDO, SR 812.219) that were revised to align with the new transitional provisions in EU MDR and IVDR have entered into force from 1 November 2023. Swissmedic has now published information about the implementation of these updates.
The Information Sheet on Economic Operators has been updated to remove outdated information and clarify some important topics.
- A few obligations of Swiss importers/distributors are reworded for clarification. The duty to immediately forward complaints and reports about suspected incidents has been changed from âTo manufacturer, if applicable to authorised representativeâ to âTo manufacturer and to authorised representativeâ. Swiss importers and distributors have to âKeep a registerâ instead of âKeep a Complaints Listâ.
- Per the new question (i), the Swiss importer must be clearly identifiable along the supply chain, even when there is no distributor. This is meant to clear doubts that might have arisen from the meaning of âdocument accompanying the deviceâ, where it was indicated that it did not necessarily need to reach the end user.
- For the extension of the validity of EC Certificates (non-IVD), both the CH-REP and the Swiss importer are responsible for checking the plausibility of the manufacturerâs self-declaration and/or the Notified Bodyâs confirmation letter under EU MDR Art. 120(3c).
Note: No explicit reference is made to the possibility of placing on the market an EU MDR device and its âlegacyâ version in parallel. Yet, Swissmedic clearly states that they rely on the EU Commissionâs practice on interpretation and points to their Q&A document. As such, question #2 in this document is presumed to apply in Switzerland, too.
Also, there is a new Information Sheet on Products without an intended medical purpose (i.e. those commonly known as âAnnex XVI productsâ), clarifying that a CH-REP is not required for Annex XVI products as long as they are not yet placed on the market under the MedDO, i.e. due to the transitional provisions. However, professionals who use these products must report serious incidents to Swissmedic, and some timelines applicable to Annex XVI products differ in the MedDO, due to the time gap with respect to Reg. (EU) 2023/1194.
Swissmedic has also created a new website for these Product groups without an intended medical purpose.
Last, Swissmedic has updated the Information sheet on FAQ on IVD notification. IVD notification to Swissmedic only applies to Swiss-based manufacturers.
European Commission
Commission Delegated Reg. (EU) 2023/2197 of EU MDR – the assignment of UDI for contact lenses
- âMaster UDI-DIâ shall be assigned to contact lens products
- Date of Application: 9 November 2025
Swissmedic
Information sheet on FAQ on IVD notification – updated version
- IVD notification to Swissmedic only applies to Swiss-based manufacturers.
- This updated InfoSheet introduces new questions:
- Question #15 on the procedure for completing the notification form for in-house IVDs
- Question #16 on the declaration of in-house IVDs meeting GSPR requirements
- Question #24 on Fees
Vigilance e-mail requirements clarification that need the attention of foreign manufacturers
- The text on Swissmedicâs webpage relative to MIR has been updated with the following clarification:
- In addition to specifying âCH-REPâ in section 1.3.1 of the MIR form upon selecting âOther, please specifyâ, the CH-REPâs contact details must be indicated in section 1.3.4 of the MIR form.
- The CH-REPâs e-mail address that has to be indicated in section 1.3.4d of the MIR form must be included in the mailing list when the foreign manufacturer (or System/Procedure Pack Producer) submits the MIR to Swissmedic.
- The text on Swissmedicâs webpage relative to Trend report & PSR & PSUR has been updated with the following clarification: The CH-REPâs e-mail address that has to be indicated in section 1.3.4f of the Trend report form must be included in the mailing list when the foreign manufacturer (or System/Procedure Pack Producer) submits Trend reports directly to Swissmedic.
- The text on Swissmedicâs webpage relative to FSCA has been updated with the following clarification: The CH-REPâs e-mail address that has to be indicated in section 5 of the FSCA form must be included in the mailing list when the foreign manufacturer or System/Procedure Pack Producer) submits FSCA reports directly to Swissmedic.
European Commission
MDCG 2023-4 MDSW – Hardware (HW) working in combination
- This new guidance document covers HW or HW components that play an essential role in the intended purpose of certain MDSW, particularly in medical mobile apps.
- As expected, for MDSW that works in combination with HW or HW components placed on the market as either a medical device or an accessory to a medical device, the MDSW manufacturer must demonstrate compliance of the combination with the EU MDR, and establish communication channels with the corresponding HW and HW manufacturer for Vigilance purposes.
- Now, when the HW or HW component (to MDSW) is NOT a medical device or an accessory to a medical device and has no intended medical purpose, the MDSW manufacturer becomes responsible for the safety, performance and reproducibility of the HW or HW component in their combined use with the MDSW, in all intended configurations.
This means that, if you have a medical mobile app that interacts with a non-medical device wearable to capture physiological parameters of users/patients, which are then further analyzed/processed by your App, your risk management, clinical evaluation, and post-market surveillance must integrate the wearable. Given the limited leverage that an MDSW manufacturer might have over a third-party HW or HW component, this requirement could represent a show-stopper.
Swissmedic
Swissmedic inspection of Swiss importers
Swissmedic has published a summary report of its inspection of Swiss importers. There were deficiencies at 23 of the 30 inspected companies, regarding in particular:
- the correct verification of the products
- the indication of the importerâs contact details
- the storage and transport conditions
- The findings were presented by Swissmedic at Swiss MedTechâs National Conference Day on October 18th, as part of a session on How to prepare for Swissmedicâs inspections.
EU Commission
The EU Commissionâs proposal for a Directive on the liability of defective products is moving forward with the approvals of the Legal Affairs Committee (JURI) and Internal Market and Consumer Protection Committee (IMCO). For more details on the development of this important legislative piece, see the EU Parliamentâs New Product Liability Directive briefing.
Swissmedic
MedDO and IvDO are revised to align with the EU MDR transitional provision.
The new versions will come into application on 01-Nov-2023. Watch out for the upcoming Swissmedicâs related guidelines, expected to be published prior to the date of application.
EU Commission
Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR published: provides clarification on the newly extended transitional provisions for products without intended purpose (âAnnex XVIâ products)
Manual on borderline and classification for medical devices under EU MDR and IVDR, updated with new cases:
- Root canal irrigation solution
- Temperature sensors embedded in orthopedic devices for compliance tracking
- System intended to produce sclerosing foam
- n-butyl-2-cyanoacrylate based adhesives
- Custom-made cranial implant
- Root canal irrigation solution
Swissmedic
swissdamed survey results report published. A few interesting insights:
- Preferred responsibilities for uploading device registration data: either by the CH-REP or by both CH-REP and the foreign manufacturer.
- Foreign manufacturers should be authorized to maintain data (via CH-REP).
- Excel as the preferred solution to upload data onto swissdamed.
English version of the updated MedDO and IvDO are now available.
