The adaptation of the transitional periods for the IVDR, published by the EU Commission in the form of  Regulation (EU) 2024/1860, came into force on 9. July 2024 and is intended to give manufacturers and notified bodies more time to implement the requirements of the IVDR. The extended transitional periods apply exclusively to legacy devices with an existing conformity certificate or declaration of conformity and are again staggered according to the risk class of the legacy device:

•           Risk class D and devices with a valid certificate under Directive 98/79/EC until 31 December 2027

•           Risk class C: until 31 December 2028

•           Risk class B and sterile devices of risk class A: until 31 Dezember 2029

 

The extension is subject to the following conditions:

1.         These devices continue to comply with Directive 98/79/EC;

2.         No significant changes have been made to the devices (according to MDCG 2022-06);

3.         The devices do not pose an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of health protection;

4.         The manufacturer has established a quality management system according to Article 10(8) of the IVDR by 26 May 2025;

5.         The manufacturer has submitted a formal application for conformity assessment to a notified body and has completed it by the following deadlines:

 

I.          26 May 2025 for risk class D devices

II.         26 May 2026 for risk class C devices

III.        26 May 2027 for risk class B devices

IV.        fore the expiry of the certificate under Directive 98/79/EC for the relevant devices

 

Devices covered by a certificate according to Directive 98/79/EC will continue to be monitored by the notified body during this period. Regardless of these extensions, the requirements of the IVDR for post-market surveillance, market surveillance, vigilance, and the registration of devices and economic operators still apply to legacy devices.

 

The EU Commission has published a Q&A on practical aspects in parallel.

 

Here you have the possibility to download the timeline in better quality and with external links as PDF.

Reminder for the necessity of the submission of Periodic Safety Update Reports.
With a certain frequency manufacturers of medical devices of risk classes IIa, IIb and III have to create a PSUR (Periodic Safety Update Report) according to MDR Art. 86 and manufacturers of In-vitro-Diagnostics of risk classes C and D have to create a PSUR according to IVDR Art. 81. For MDR-/ IVDR-certified devices these PSURs have to be submitted to the Notified Body and will be assessed by it according to the requirements.

MDCG 2022-21 contains comprehensive explanations regarding the content of the PSUR for medical devices.

For MDR-/ IVDR-certified devices for which mdc did not receive a PSUR yet (in consideration of the period of creation), mdc will contact the manufacturers to remind the necessity and deadlines.

By today’s publication in the official European database NANDO, the list of Notified Bodies under Regulation (EU) 2017/746 (IVDR) has grown by another position with mdc medical device certification GmbH.
With today’s publication in the European database NANDO, we as a Notified Body have received the official designation under Regulation (EU) 2017/746 (IVDR). The regulation, adopted in 2017, applies throughout the EU and replaces the former Directive 98/79/EC. After several years of extensive preparation, review and approval, we are very proud to have reached this important milestone for us and our customers. The management of mdc would like to thank all employees who have contributed to the achievement of this goal in the company’s history and all customers for their loyalty during the long application phase.

We are very much looking forward to being your competent partner for the CE marking of your products also under the new regulations and are at your disposal for corresponding inquiries.

Contact: ivd(at)mdc-ce.de

With the position papers MDCG 2022-4 and MDCG 2022-15, Notified Bodies are requested to identify relevant certificates (under Directive 93/42/EEC and 98/79/EC) which are subject to surveillance according to Article 120 (3) of the MDR or Article 110 (3) of the IVDR. The requirement for adequate surveillance of existing legacy devices1/2 by Notified Bodies is sharpened and should be reflected in the audit. This means that the following aspects will become a focus of the audit:

• Transition strategy to MDR / IVDR
• Assessment of (non-) significant changes according to MDCG 2020-3 or MDCG 2022-6
• Adjustments of the requirements according to Article 120 (3) of the MDR or Article 110 (3) of the IVDR in the QMS (including post-market surveillance (Annex III of the MDR / IVDR), market surveillance, vigilance and registration of economic operators and devices)
• Assess whether all appropriate processes related to post-market surveillance, including risk management and performance data, are included in the post-market surveillance plan

For manufacturers, in addition to maintaining the QM system, all requirements must be implemented or mapped.

1Products placed on the market under Article 120(3) of the MDR after the date of application of the MDR (26 May 2021) and until the end of the transitional period on 26 May 2024, provided that certain conditions are met.

2Products placed on the market under Article 110(3) of the IVDR after the date of application of the IVDR (26 May 2022) and until the end of the respective transitional period referred to in the second or third subparagraph of Article 110(3), provided that certain conditions are met.

By Regulation (EU) 2022/112, the EU has amended the transition provisions for certain in-vitro diagnostic medical devices and postponed the date of application for „in-house devices” to 26 May 2028. Even though the main date of application remains on 26 May 2022, the new legal framework allows for longer transition periods for in-vitro diagnostic medical devices, which are already on the market:

• Certificates issued by Notified Bodies under Directive 98/79/EC will expire on 27 May 2025 at the latest. This means that devices, which are certified by a Notified Body according to Directive 98/79/EC, may be placed on the market until 26 May 2025.
• Legacy devices, which are covered prior to 26 May 2022 by a valid Declaration of Conformity according to Directive 98/79/EC and are placed on the market without involvement of a Notified Body can continue to be placed on the market until the following deadlines, depending on their classification:

1. 26 May 2025 for class D devices;
2. 26 May 2026 for class C devices;
3. 26 May 2027 for class B devices;
4. 26 May 2027 for sterile class A devices.

Additionally, deadlines for making available on the market and putting into service have been defined.

For the handling of changes of devices, which are placed on the market under Directive 98/79/EC, we expect a guidance document similar to MDCG 2020-3 (Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD)

The requirements of the IVDR regarding post-market surveillance, market surveillance, vigilance as well as the registration of economic operators and devices will apply to all in-vitro diagnostic medical devices from 26 May 2022.

On 14.10.2021, the EU Commission published a proposal for the extension of transitional periods for the IVDR. According to this proposal, the start of application on 26.05.2022 is to remain, but applies only to new devices and devices of class A (non-sterile). Old products which are covered by valid certification by a notified body or a declaration of conformity according to IVDD before 26.05.2022 shall be subject to longer transitional periods which end in the years 2025 to 2027 depending on the certification under IVDD or their classification. These products can then continue to be placed on the market by complying with the IVDD and with only individual aspects of the IVDR. EU Council and Parliament still have to agree to the proposal. The press release of the EU Commission with further links to the amendment proposal and a Q&A document on this can be found here.

At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the MDR (26 May 2021) or IVDR (26 May 2022), with reference to Art. 120 MDR or Article 110 IVDR.

However, in the event of non-significant changes that require an amendment to the declaration of conformity (e.g. change of name, change of address), the existing declaration of conformity is supplemented by an addendum or annex in accordance with the directive.

 

This has now been clarified by the German market surveillance authorities (AGMP) and it is particularly pointed out that there may NOT be a new declaration of conformity according to MDD/ IVDD, but only a “supplement” (see above) to the declaration of conformity issued before 2021-05-26 (MDD)/ 2022-05-26 (IVDD), which clearly states the non-significant changes (e.g. also new product variants).

At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the MDR (26 May 2021) or IVDR (26 May 2022), with reference to Art. 120 MDR or Article 110 IVDR.

However, in the event of non-significant changes that require an amendment to the declaration of conformity (e.g. change of name, change of address), the existing declaration of conformity is supplemented by an addendum or annex in accordance with the directive.

This has now been clarified by the German market surveillance authorities (AGMP) and it is particularly pointed out that there may NOT be a new declaration of conformity according to MDD/ IVDD, but only a “supplement” (see above) to the declaration of conformity issued before 2021-05-26 (MDD)/ 2022-05-26 (IVDD), which clearly states the non-significant changes (e.g. also new product variants).

The establishment of the company mdc medical device certification GmbH was commercially registered 25 years ago on December 10, 1996.

Already since 1994 “mdc medical device certification” was the name of a division of Dr. Müller-Lierheim GmbH and became legally independent when the company was founded in 1996.

Since the merger with the certification body for medical devices of ZDH-ZERT e.V. in 2000, mdc is based in Stuttgart. Further office locations are in Berlin, Tuttlingen and Vienna. In addition, the first non-European branch will be opened in Haifa (Israel) in a few weeks. In the past 25 years the number of employees has increased from three to over 100. In addition, there are around 70 freelance auditors, technical experts and inspectors. The daughter company of ZDH-ZERT e.V. is in the meantime not only one of the leading notified bodies and prequalification bodies, but is also the market leader in Germany regarding certification of QM systems in the area of medical aids .

mdc has always focused its activities on the field of medical devices and related areas. The range currently covers the activity as a notified body under Regulation (EU) 2017/745 for medical devices (MDR) and under Directive 98/79/ EC for in-vitro diagnostic devices (IVDD), as an accredited certification body for QM systems according to ISO 13485 and ISO 9001, as well as an accredited prequalification body in the field of medical aids. Recognitions in Ukraine and Taiwan, audits under the Medical Device Single Audit Program (MDSAP) within the framework of a cooperation and the organization of public face-to-face and online seminars on topics related to quality management and regulatory affairs complete the offer. Under Regulation (EU) 2017/746 (IVDR) mdc is at an advanced stage of the designation process.

On the occasion of the 25th anniversary of the company, the managing director Harald Rentschler, who took up this position when the company was founded, was handed out a honorary certificate from the Chamber of Industry and Commerce in Stuttgart by its the managing director Dr. Susanne Herre. He thanks everyone who has accompanied the company on its successful path.

Dear Madam or Sir!

As of 2021-05-26, Directive 93/42/EEC on medical devices (hereinafter MDD) was withdrawn and thus became invalid. Consequently, according to Article 120 (1) of Regulation (EU) 2017/745 on medical devices (hereinafter MDR), the designation of all Notified Bodies according to MDD and also our designation was withdrawn.

This means on the one hand that we as your Notified Body according to MDD can no longer issue new certificates or extensions of certificates. The validity of previously issued certificates will continue to exist if they are subject to appropriate monitoring by the Notified Body in accordance with Article 120 (3) MDR, last sentence.

This situation also means that an essential part of the certification contract has ceased to exist, as mdc is no longer a Notified Body according to MDD. (The designations as Notified Body according to MDR as well as IVDD are unaffected and remain in place!) Therefore, we will approach you in the next few days with a supplementary agreement to the existing certification contract in order to enable the monitoring required by Article 120 (3) MDR on a contractually sound basis. This is an essential prerequisite for the continued validity of the issued certificates according to MDD.

Furthermore, we would like to inform you about new MDCG guidance documents. The MDCG Guidance Documents provide assistance for the harmonized interpretation of the legal text of the MDR by the European Commission and National Competent Authorities. MDCG guidance documents should be taken into account when implementing a QM system and when creating and maintaining technical documentation.

With 2021-10-21 MDCG 2021-25[1] on the handling of legacy devices was published. Legacy devices are defined as products that are certified according to the MDD and may still be placed on the market during the transitional period specified in Article 120 (3) MDR under the conditions specified therein until the end of the term of the respective certificate or the transitional period under MDD requirements. Such legacy devices may continue to be placed on the market, provided that their safety and performance under the MDD requirements is proven. We have already published several news articles on our homepage, to which we may refer, e.g.

• 2021-05-26: Start of application of the new Medical Device Regulation
• Changes in procedures according to MDD due to date of application of MDR

 

However, the requirements of Article 120 (3) MDR left room for interpretation in some aspects, which was clarified by the MDCG 2021-25.

 

1. Responsible Person according to Art. 15

The first and most important clarification is that no “person responsible for regulatory compliance” (PRRC according to Art. 15 MDR or IVDR) needs to be appointed for these legacy devices.

Nevertheless this provision of Article 15 MDR and IVDR replaces the requirement to appoint a safety officer in Germany and Austria. The previous requirement to appoint a safety officer (e.g. according to § 31 MPG or § 78 Austrian MPG 1996) exists since 2021-05-26 only for manufacturers of in vitro diagnostic medical devices; the MPDG[2], as well as the Austrian MPG 2021[3] do not contain this requirement anymore.  Nevertheless, we still recommend that manufacturers who solely place legacy devices on the market to also adapt their processes. In particular, the responsibilities for fulfilling the reporting obligations should be clearly assigned to a “responsible person”. However, since this person is not yet legally obligatory, we also do not yet see it as obligatory that the qualification requirements specified in the MDR are fully complied with.

If the company is a manufacturer of class I products, which are fully subject to the MDR since 2021-05-26 (i.e. no higher classification by the MDR), the requirements of Article 15 MDR are fully applicable in any case.

2. Periodic Safety Update Report – PSUR according to Art. 86.

Another clarification concerns the requirements for post-market surveillance (PMS). The requirements of Articles 82 to 86 MDR as well as Annex III have to be fulfilled by every medical device manufacturer since 2021-05-26. This means that a PMS plan must also be created for legacy devices and documented as part of the technical documentation. The detailed contents are specified in Annex III of the MDR.

The second requirement is that, as specified in this plan, a Periodic Safety Update Report (PSUR) must be prepared and updated for all Class IIa, IIb, and III medical devices, in accordance with Article 86 of the MDR. The MDCG guidance document made it clear that this report is also expected from manufacturers of legacy devices.

This PSUR must be made available to market surveillance authorities upon request. The PSUR of legacy devices must be made available to the Notified Body as part of surveillance audits.

At mdc, we will check the timely implementation of these requirements in detail during the audit. This means that a PMS plan must be available for legacy devices since 2021-05-26, the contents of the plan must meet the content requirements of Annex III of the MDR. Likewise, the plan must specify the date of initial creation and/or the interval for updating the PSUR. The periods for initial preparation and further updating may not exceed one year for class IIb and III medical devices and two years for class IIa medical devices.

From the date specified in the plan, the PSUR must also be available and its content will be checked (on a sample basis) as part of the audit. In addition to the summary of reportable/serious incidents, further information must be provided. This includes for example

• an overview of non-serious incidents,
• a trending of non-serious incidents or expected adverse events,
• the conclusions of the benefit-risk assessment,
• the main findings of the PMCF assessment report, if available; and
• the total sales volume of the product and an estimate of the number of applications/frequency of use.

3. Changes to legacy products

We would also like to remind you of the conditions under which the MDD certificate can continue to be maintained for legacy devices. In addition to the continuous monitoring by the Notified Body in the context of audits as well as sampling of the Technical Documentation, the products must not undergo any significant change as defined in Article 120 (3) and further detailed in MDCG 2020-3[4]. In particular, MDCG 2020-3 provides a detailed description including examples and a decision tree for evaluating changes. Implementing a significant change will invalidate the issued MDD certificate. Such a change may only be implemented under a certification according to MDR.

Irrespective of this, the basic obligation remains to notify the Notified Body of changes to the product, the QM system, the product range, etc., which are described in Guidance Document NBOG 2014-3[5]. These changes referred to as “substantial changes” need further evaluation by the Notified Body before the implementation. Changes that are reportable as a “substancial change” but do not meet the definition of a “significant change” may be implemented after evaluation by the Notified Body. Please contact the project team if you have any questions.

During the on-site audit, it will be checked in particular whether the company has implemented procedures to classify planned changes and, if necessary, to report them to the Notified Body. Furthermore, the planned and implemented changes shall be evaluated with regard to their classification (significant and/or substantial). The auditor(s) shall confirm the validity of the manufacturer’s classification.

4. Transition to the MDR

We would like to remind you once again that the transitional periods for certificates according to the MDD will expire by 2024-05-26 at the latest. By this date, all devices of classes Im, Ir, Is, IIa, IIb and III must have at least one certificate according to MDR if they shall continue to be placed on the market in Europe. For class III medical devices, both certificates (review of the Technical Documentation and QM system) must be valid according to the same regulatory framework (MDD or MDR).

The certification procedures according to MDR are real initial certifications. The procedures involve significantly more effort, both formally and in terms of content, and therefore require significantly more time than under MDD. Experience from the first 1.5 years has also shown that the requirements for the restructuring of the technical documentation were repeatedly underestimated and therefore TD test reports with a very high number of non-conformities are not uncommon. In order to be able to complete the certification procedures according to MDR in time until the end of the validity of the MDD certificates, we would therefore like to ask you to coordinate the planned process with your mdc project team at an early stage – only by submitting the QM documentation and all technical documentations in 2022 can the possibility of certification under MDR until May 2024 be safeguarded. We must also emphasize the need for early submission with the fact that we are currently already unable to offer certification under the MDR to individual existing customers for resource reasons.

 

If you have any questions, please do not hesitate to contact us

Daniel Kraushaar                                                     Meinrad Guggenbichler

Head of Business Unit Medical Devices              Head of Notified Body Medical Devices

 

 

[1] MDCG 2021-25: Application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf

[2] MPDG: Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte: www.gesetze-im-internet.de/mpdg/

[3] MPG 2021: Medizinproduktegesetz 2021: https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20011580

[4] MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR: ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf

[5] NBOG 2014-3: Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System: www.doks.nbog.eu/Doks/NBOG_BPG_2014_3.pdf