As of March 20, 2023, Regulation (EU) 2023/607 was published to smoothen the transition from MDD (and AIMDD) to MDR certification of devices on the market and to assure availability of medical devices on the European market. Manufacturers of devices certified according to Medical Device Directive (MDD), also known as “legacy devices” according to MDR Article 120, can now benefit from longer periods for the transition of MDD certification to MDR. In order to be able to benefit from this extension let’s delve into the key highlights:

Extension of MDR validity of certificates:
All certificates not expired on March 20, 2023 have been extended by definition until December 31, 2027 (for class III and class IIb implantable legacy devices) and until December 31, 2028 (for other class IIb and class IIa, as well as class Im and Is legacy devices).

It has to be noted that an additional prerequisite for placing devices on the market has been introduced: additional to the valid MDD certificate the manufacturer must have applied for the individual device (or a successor device) for MDR certification by May 26, 2024.
The notified body can then issue a confirmation letter (as defined in the Q&A document by the European Commission) confirming formally the validity of the MDD certificate.

However, it’s important to note that the extension is subject to certain conditions to benefiting from the new transition period. Manufacturers must:

• by May 26, 2024 establish a quality management system (QMS) compliant with MDR;
• by May 26, 2024 submit a formal application for conformity assessment under MDR;
• by September 26, 2024 have a mutually signed written agreement with the Notified Body for conformity assessment under MDR.

Additionally, the extension of the transitional regime only applies to MDR legacy devices that:

• continue to comply with Directive 93/42/EEC;
• do not undergo significant changes in design or intended use;
• do not pose unacceptable risks to the health and safety of patients and users.

The new regulation also introduces additional requirements for legacy devices with expired certificates. Also such devices may benefit from the extended transition period either if the manufacturer had concluded a contract with a Notified Body for conformity assessment under the MDR before the expiration of the MDD certificate or has obtained exemptions under Article 97 or 59 MDR.

This extension of the transition period addresses the demands of the medical device industry, which has long sought a more flexible certification deadline for MDD legacy devices. It is good news for medical device manufacturers. However, it is crucial to act promptly and meet the first deadline of May 26, 2024, to ensure compliance with the new rules.

In this context we may also remind on the revision of MDCG 2020-3 (Rev. 1) on the definition of significant changes. The document gives clarification on the conditions when a change can be considers as “non-significant” and thus be implemented under an existing MDD certificate. This is especially crucial to adopt devices in the next four to five years to maintain safety and availability in the transition period.

Additional transition periods for Custom made devices:
Implantable class III custom made devices need to have a quality management certification according to Annex IX, by May 26, 2026 in order to continue to place these devices on the market.

Removal of the “sell-off” period:
The new regulation eliminates the previously defined “sell-off” period stated in MDR, Article 120(4).

Additional transition periods for Annex XVI devices:
Also the timelines for implementation of MDR for products without an intended medical purpose (Annex XVI, MDR) have recently been extended. By Commission Implementing Regulation (EU) 2022/2346 the legal framework, i.e. the Common Specifications, for certification of Annex XVI devices was generally established. The original version was also amended to align the transition periods with definitions of Regulation (EU) 2023/607 – this was published on June 20 2023 as Commission Implementing Regulation (EU) 2023/1194. It was clarified that if the device was MDD certified timelines of Art. 120 MDR (see above) shall apply. In all other cases (device not MDD certified) also the timeline for transition of the devices to MDR certification are extended.

Prerequisites:

• Device was lawfully marketed in the Union before 22 June 2023
• in continuous accordance with applicable requirements and
• not substantially changed.

Applicable Timelines for Annex-XVI-devices the manufacturer intends to perform or is performing a clinical investigation (CI):

• 22 June 2024: confirmation by the National Competent Authority acc. to Art. 70 (1) or (3) MDR that the application for the CI is complete;
• 23 December 2024: the sponsor must have started the CI;
• 1 January 2028: written agreement for the conformity assessment has been signed with the Notified Body must be in place;
• 31 December 2029: end of transition period.

Applicable Timelines for Annex-XVI-devices the manufacturer does not perform a clinical investigation:

• 1 January 2027: written agreement for the conformity assessment has been signed with the Notified Body must be in place
• 31 December 2028: end of transition period

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.

On 20 Mar. 2023, the European Commission published Regulation (EU) 2023/607 extending the transitional periods for devices requiring a Notified Body for conformity assessment under Regulation (EU) 2017/745 (MDR).

UPDATE: On July 2023 the European Commission has additionally published a updated Q&A document on the extension of the timelines. The information can be found on the EC website:

https://health.ec.europa.eu/latest-updates/qa-practical-aspects-related-implementation-regulation-eu-2023607-extension-mdr-transitional-period-2023-03-28_en

The new regulation newly regulates the validity of AIMDD and MDD certificates and defines requirements for the first placing on the market of “legacy devices” (as per MDCG 2021-25), even if the validity of the underlying certificates according to the directive (MDD or AIMDD) has formally expired.

Overview of the changes:

1. Extension of the transitional periods for the first placing on the market of devices based on certificates according to MDD or AIMDD, for all devices for which an application for certification (see below) according to MDR was submitted before the expiry of the MDD certificate until 31 Dec. 2027 (Class III and implantable devices Class IIb [with exceptions]) or until 31 Dec. 2028 (all other devices).
2. Extension of the transition period for class I devices (MDD) that are classified higher under MDR until Dec. 31, 2028.
3. Extension of transition period for Class III custom-made devices until Dec. 31, 2027.

For these devices (except custom-made devices), the manufacturer must have established a QM system according to MDR by 26 May 2024 at the latest. The second, essential prerequisite for being able to benefit from the extended timelines is a written contract between the manufacturer and the notified body for certification according to MDR (certification contract). This contract must be applied for at the latest before the expiry of the MDD certificate and must cover all products for which the extension of the transitional periods is to be claimed. The basis of the contract is the availability of the technical documentation in accordance with the requirements of the MDR.

In order to be able to submit an application for certification – either initial MDR certification or extension of the MDR certification for new device groups – we require a questionnaire (initial certification) or an amended list of medical devices (a notification of change alone is not sufficient). On this basis, we will provide you with an offer for certification. This offer is the basis for your application for certification and subsequently for the final certification contract. We will implement the requirements for the contract in such a way that, together with the application for certification, at least one complete technical documentation must be submitted for review in addition to the documentation of the QM system. The technical documentation according to MDR requirements for the other products covered by the certification contract must also be available at the time of application, but can be submitted for review at a later date according to an agreed plan.

In order to be able to issue the confirmation letter proposed by the EU Commission, a contract for the monitoring of the (formally expired) MDD certificates must also be concluded. On the basis of this communication this confirmation letter can be issued confirming that products may continue to be placed on the market with the CE mark and mdc’s identification number 0483. We are preparing the corresponding application procedure and will make them available as soon as possible.

Alternatively, the manufacturer (or his European authorized representative) can apply for an exemption according to Art. 97 MDR at the responsible market surveillance authority, this is independent of the status of the MDD certificates.

Another significant change is also the elimination of the sell-by period for medical devices and In- vitro Diagnostic Devices placed on the market under AIMDD, MDD and IVDD.

You can also find the text of the regulation at

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32023R0607

Dear Sir or Madam,

in December 2021, the German Institute for Standardisation (DIN) published the new edition of DIN EN ISO 13485. The standard DIN EN ISO 13485:2021 contains requirements for a quality management system for use by organisations that are required to demonstrate their ability to provide medical devices and related services – with the aim of continuously meeting applicable regulatory requirements and customer requirements.

Following the entry into force of Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices respectively, it was necessary to replace the European Annexes Z of EN ISO 13485, which represented the relationship between sections of the standard and EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC respectively.
Annexes Z have been redrafted on the basis of the current EU regulations on medical devices and in vitro diagnostic medical devices, respectively, so that the relationship between sections of the standard and Regulations (EU) 2017/745 and 2017/746 is now presented.

Implementing Decisions (EU) 2022/6 and 2022/15 of 4 and 6 January 2022 respectively harmonised the new version of the standard for Regulations (EU) 2017/45 and 2017/746.

In addition to the amendment of the (informative) Annexes Z, corrections and editorial revisions were included; however, there were no normative changes to DIN EN ISO 13485:2021 compared to DIN EN ISO 13485:2016.

The standard DIN EN ISO 13485:2021 replaces DIN EN ISO 13485 Corrigendum 1:2017-07, DIN EN ISO 13485:2016-08.

The deadline for the conversion of certificates according to DIN EN ISO 13485:2016 to DIN EN ISO 13485:2021 is 26 May 2024.

For procedures with certificates according to DIN EN ISO 13485:2016, for which the term ends BEFORE 26.05.2024, the conversion to DIN EN ISO 13485:2021 takes place within the framework of the next re-certification.

For procedures with certificates according to DIN EN ISO 13485:2016, for which the term ends AFTER 26.05.2024, the changeover to DIN EN ISO 13485:2021 takes place within the framework of the next surveillance. You will receive the information on the changeover with the order confirmation for the next surveillance procedure. The certificate according to DIN EN ISO 13485:2021 will then be issued for the remaining term of the certificate according to DIN EN ISO 13485:2016.

The conversion to DIN EN ISO 13485:2021 within the scope of surveillance audits begins for procedures with audit dates from 01.09.2022.

The conversion within the scope of a surveillance audit for certificates with a limited term until 26.05.2024 or beyond is carried out for you as a customer at no extra charge; including the reissue of the certificate according to DIN EN ISO 13485:2021 (1 certificate).

With the issuance of the certificate according to DIN EN ISO 13485:2021, existing certificate translations – based on the certificate according to DIN EN ISO 13485:2016 – lose their basis and thus their validity. If you require translations based on the newly issued certificate, these are subject to a charge (current price lists).

Certificates according to DIN EN ISO 13485:2016 with a limited validity period until 26.05.2024 due to DAkkS requirements will also be converted during the next surveillance audit.

The requirements of the DAkkS and the background to the conversion can be found here:
https://www.dakks.de/de/aktuelle-meldung/din-veroeffentlicht-neue-norm-din-en-iso-13485-2021-12.html

Gabriele Meyer
Head of Certification Body QM Systems

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

The new MDR will replace the currently valid medical device directives (MDD and AIMDD) on May 26, 2021. A corresponding amendment to the German MPG is also available as the Medical Devices Amendment Act. The exact aspects of the MDR, which have to be checked in the context of surveillance procedures according to MDD, are for example presented in the transition rules in Art. 120 MDR. If these requirements are not met by a manufacturer after 25.05.2021, this constitutes a deviation from the applicable legal requirement. In particular, the requirements of Art. 120 (3) MDR are to be implemented in the QM system of a guideline manufacturer:

1. post-market surveillance (PMS).

2. vigilance (incident reporting)

3. registration of economic operators and products

1. Post-market surveillance (PMS)
To post-market surveillance MDR primary reference to the requirements on a PMS system laid out in Articles 83 to 86 MDR and Annex III MDR. The manufacturer shall plan the PMS system. For class I medical devices, a PMS report must be prepared if necessary; this report must be submitted to the market surveillance authority upon request (Art. 85 MDR). For higher class medical devices (IIa, IIb and III) a Periodic Safety Update Report (PSUR) shall be prepared (Art. 86 MDR); this shall be submitted to the Notified Body. Deadlines for regular updating and submission are specified depending on the risk class: annually for class III and IIb devices, every two years for class IIa devices. In addition to assessing the impact on the risk-benefit balance, these reports shall also include information on where the devices are placed on the market. Details on the content of the reports are specified in Articles 85 and 86 MDR.

2 Vigilance
Requirements on incident reporting have been tightened in Article 87 MDR. On the one hand, the Europe-wide standardized reporting deadlines replace the previous reporting deadlines:

• 2 days for serious risk to public health.
• Serious incident: Immediately, but no later than 15 days.
• Death or unforeseen serious deterioration of health: immediately, but no later than 10 days.

On the other hand, requirements for summary reporting (Periodic Summary Reporting – Art. 87 (9) MDR) as well as trend reporting (Art. 88 MDR) for expected adverse events or non-serious events are specified. As soon as the EUDAMED database is operational it shall be used for the reporting process.

3. Registration of economic operators and products.
Requirements for registration of products under the MDD are detailed in MDCG 2019-5. Registration of legacy devices shall be completed within 24 months (6 + 18 months) after availability of EUDAMED. However, in the case of incidents or field safety corrective actions (FSCA) reportable via the EUDAMED portal the registration has to be considered before the end of the transition period in order to facilitate the incident report. The obligation to register devices subsequently results in the obligation to register the respective manufacturer or authorized representatives according to national requirements. The general opinion is that the Responsible Person (Art. 15 MDR) must be implemented from the date of application of the MDR, i.e. from 25.05.2021.

Validity of directive certificates from the date of application of the regulation
For certificates according to Dir. 90/385/EEC (AIMDD) Dir.93/42/EEC (MDD) or Dir.98/79/EC (IVDD) the respective validity dates and conditions apply (e.g. connection between certificates according to Annex II.4 and the certificates according to Annex II without 4). However, after expiry of the transition periods to the MDR (2021-05-26) as well as to the IVDR (2022-05-26) certificates according to the directives (AIMDD, MDD and IVDD) can no longer be newly issued or amended. However, Art. 120 (3) MDR or Art. 110 (3) IVDR define that for maintaining the certificates of such products, no significant changes in design or intended purpose may be implemented. A substantial change after the end of the transition period to a product that is placed on the market on the basis of a certificate according to one of the two directives (MDD or IVDD) will result in void of the original certificate. i.e. the change and subsequently the entire product must be subjected to a certification procedure according to MDR. However, this does not affect the obligation to notify changes to the Notified Body. MDCG has published a guidance document (MDCG 2020-3) which sets out which changes are interpreted as “significant change” under the MDR. This document must be used as the basis for evaluating any change for impact on existing certification after the end of the transition period.