Here we will look back at the European regulatory changes and announcements from 2022 and look forward to the important deadlines and anticipated announcements for 2023.

NOTE1: Europe = EU-27, Iceland, Liechtenstein, Norway, Turkey, and Northern Ireland.

NOTE2: The 2022 recap is not exhaustive; it includes the updates that may be interesting to a wide pool of manufacturers.

2022 Recap

More information on the below topics can be found in our: EU Regulatory Updates

January

• • MDCG publishes guidance on clinical evidence requirements for IVDs: MDCG 2022-2

February

• • MDCG publishes guidance on Notified Body surveillance audits for legacy (MDD/AIMDD) medical devices: MDCG 2022-4
    • Legacy devices are subject to certain obligations under the MDR, such as post-market surveillance, market surveillance, vigilance, and registration requirements. The guidance confirms that manufacturers should not be audited to non-applicable items, such as designating a Person Responsible for Regulatory Compliance (PRRC) or UDI.

April

• • EU Commission publishes a Notice to Stakeholders, confirming that the EU-Turkey Customs Union Agreement will apply to MDR/IVDR products, the same as it did for MDD/AIMDD/IVDD products. i.e.,
    • Manufacturers located in the European Economic Area (EEA) do not need an Authorized Representative to place devices onto the Turkish market and vice versa; and foreign manufacturers may appoint an EU Authorized Representative located in Turkey to represent them in the EEA.
    • Turkey is entitled to designate Notified Bodies to the MDR/IVDR; they will have the same rights and obligations as Notified Bodies located in the EU; those CE Marked devices can freely circulate into the EEA.

• • The MDCG publishes a guidance document on borderline between MDR medical devices and medicinal products: MDCG 2022-5

May

• • EU Commission publishes a Notice to Stakeholders, confirming that Switzerland is no longer part of the European Single Market for IVD devices as of the IVDR’s date of application: 26 May 2022.
    • With this, Swiss manufacturers require an EU Authorized Representative; any CE Certificates issued by a Swiss Notified Body will no longer be recognized in Europe; and any manufacturers who had a Swiss-based Authorized Representative must appoint a new Authorized Representative established in the European Economic Area.
  • New Harmonized Standards are adopted and published in the Official Journal of the European Union (OJEU), including EN ISO 14971:2019 on Risk Management for Medical Devices.
  • The MDCG publishes guidance on the European UDI system: MDCG 2022-7
    • It includes guidance on product & packaging changes; system/procedure packs & kits; UDI for promotional packs and marketing-related samples; traceability; Basic UDI-DI; and more.
  • IVDR date of application arrives: 26 May 2022
    • Class A non-sterile devices must comply with the IVDR on its date of application.
    • Remaining device classes must comply according to the progressive rollout schedule.
    • MDCG releases multiple guidance documents as a result:
      • MDCG 2022-6: Legacy device (IVDD CE Marked) transition requirements and significant changes
      • MDCG 2022-8: Confirmation regarding which aspects of the IVDR apply to legacy devices
      • MDCG 2022-9: Summary of Safety and Performance (SSP) template for Class C and D IVDR CE marked devices

June

• • The MDCG issues another warning to the industry. Essentially the message is: do not delay your MDR transition or you risk being off the market.
  • The Competent Authorities for Medical Devices (CAMD) issues new guidance document for: Certificates of Free Sale
    • It establishes a common practice amongst the European Competent Authorities regarding when and how to issue Free Sale Certificates.
    • It also addresses if certificates can be issued for legacy devices and if they can include both MDD/AIMDD and MDR devices.

July

• • EUDAMED’s ‘Go Live’ date pushed out to Q2 2024. This is the third postponement to EUDAMED.
    • If this date is adhered to, then the mandatory usage dates become:
      • Q4 2024: actor registration, vigilance, clinical investigation & performance studies, and market surveillance modules.
      • Q2 2026: UDI/Device registration and Notified Body & Certificates modules.
    • Released modules may be used on a voluntary basis until the mandatory deadlines.
    • In the meantime, the device registration requirements under the MDD/AIMDD/IVDD continue to apply: EU Registration Requirements
  • The MDCG publishes guidance on alternative solutions until EUDAMED is fully functional: MDCG 2022-12

August

• • New 2022 version of the Blue Guide is released.
    • It was last published in 2016.
    • The Blue Guide is not specific to medical devices, but does include definitions and common understandings that also apply to medical devices, such as the definition of ‘placing on the market’.
  • The MDCG publishes a position Paper on Notified Body capacity related to MDR/IVDR CE marking: MDCG 2022-14
    • • The MDCG recognizes the lack of Notified Body capacity and offers solutions to both Notified Bodies and manufacturers on how to streamline the CE Marking process and alleviate the workload. It includes recommendations such as:
        • New guidance documents should not be immediately applied to active applications unless it will help reduce the review time.
  • The EU Commissions released a draft implementing regulation on the proposed classifications for products without an intended purpose, i.e., those products that do not have a medical indication but are regulated under Annex XVI of the MDR irrespective.
    • • e.g., proposal to classify laser hair removal products as Class IIa and liposuction equipment as Class IIb.

September

• • The Manual on Borderline and Classification is released. The manual is not intended to replace the other classification guidance documents. Instead, it is intended to record the agreements reached by the Borderline and Classification Working Group (BCWG), when a decision is reached on a borderline product.
    • This is a ‘living’ document and will be updated as new products are assessed and added, e.g., it was updated in December 2022 to include additional decisions.

• • Team Notified Body issues a Position Paper on Hybrid Audits. It:
    • Promotes the continued use of hybrid audits for a variety of reasons, including increasing auditor capacity and reduction in “burnout for auditors.”
    • Provides examples of the items that could be assessed remotely versus those that should be assessed onsite, such as production and final inspection.

November

• • The MDCG release a guidance on Authorized Representatives: MDCG 2022-16
    • It addresses items such as:
      • Recommendation that Authorized Representatives verify their manufacturers have sufficient measures related to financial coverage, e.g., product liability insurance.
      • That the manufacturers technical file documentation should be “permanently available” to the Authorized Representative.

December

• • The EU Council supports a decision to postpone the MDR.
    • The proposed (not final) dates from the 26 May 2024 deadline, are to:
      • Class III and IIb devices – May 2027
      • Class IIa and I devices – May 2028
    • The EU Council will present a legislative proposal early 2023
  • The MDCG issues a guidance document regarding how to market under MDR Article 97, after an MDD/AIMDD CE Certificate expires: MDCG 2022-18
    • It covers the criteria to be eligible, the documents that will be requested by the Competent Authorities, what happens after Article 97(1) is granted, and the manufacturer’s continuing obligations
  • The MDCG issues the long-awaited guidance on Periodic Safety Update Reports (PSURs) and provides a template: MDCG 2022-21
    • It addresses questions such as: can multiple device families be bundled into a single PSUR and what data should be considered when preparing the PSUR.
  • The MDCG updates its guidance on Notified Body surveillance audits for legacy devices, originally published in February 2022: MDCG 2022-4 Rev. 1
    • Essentially: it deletes requirements and changes wording to ease the surveillance process.

2023 Look Forward

Known Deadlines

• • By 26 May 2023:
    • UDI Carrier is required on labeling for MDR CE Marked Class IIa/IIb and IVDR CE Marked Class D devices.
    • UDI Direct Marking is required for MDR CE marked reusable implantable and Class III devices.

Expected Announcements

• • The EU Council’s legislative proposal to delay the MDR, which will have more information on the new compliance dates and which devices will or will not be eligible.
  • If all six EUDAMED modules will be ready by Q4 2023, to undergo an independent audit in early 2024.
    • EUDAMED must pass this independent audit to be deemed fully functional and published in the Official Journal of the European Union.
  • Continued release of harmonized standards, common specifications and MDCG guidance documents.