European regulators have published new guidance documents addressing persons responsible for managing compliance with the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).

PRRC under the MDR and IVDR

The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators.

A manufacturer’s PRRC must have either a formal qualification (university degree) in addition to a minimum of one year’s professional experience in medical device regulatory affairs or quality management; or four years of experience in regulatory affairs or quality management pertaining to medical devices.

• PRRC qualifications obtained outside the European Union should be recognized by an EU Member State as equivalent to an EU qualification;
• Organizations that have more than one legal manufacturer must designate a PRRC for each of its manufacturing entities;
• European regulators will generally assume that manufacturers based outside the EU will have PRRCs located outside the EU, as well.

Micro and small manufacturers will have the option to subcontract their PRRC functions to third parties that meet qualifications laid out for manufacturer PRRCs in Article 15 of the MDR.

European Authorized Representatives may also outsource their PRRC responsibilities to third parties, provided their subcontractors meet stated qualifications.

Finally, the guidance explicitly forbids a single individual from serving as PRRC for both an Authorized Representative and a manufacturer based outside the EU.

“There is a clear desire within the Regulations for the authorised representative to be adding an additional level of scrutiny and ensure that the supervision and control of the manufacture of devices, and the relevant post-market surveillance and vigilance activities are adequately effected,” states the guidance.

Additional European MDR and IVDR resources from Emergo by UL:

• European CE Mark strategy for medical device companies
• European CE Marking consulting for IVD devices
• European Authorized Representative in-country representation
• On-site MDR training for manufacturers
• Whitepaper: Understanding Europe’s Medical Devices Regulation (MDR)
• Whitepaper: The European In-vitro Diagnostic Medical Devices Regulation (IVDR)

The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD).

The guidance augments issues covered by MEDDEV 2.12-1 rev. 8, including Manufacturer’s Incident Reports (MIR), and field safety actions and notices, and device-specific vigilance reporting recommendations.

Updated MIR incident reporting form

First, the guidance covers an updated version of the MIR form that will become mandatory for manufacturers certified under the MDD starting in January 2020.

The updated MIR includes coding and terminology based on International Medical Device Regulators Forum (IMDRF) recommendations; provides a definition of and new formatting requirements for similar reportable incidents; and paves the way for use of SRN and UDI data in MRIs, which will become mandatory under the Medical Devices Regulation (MDR).

Field safety-related definitions, distribution and content

The guidance also distinguishes between field safety corrective actions (FSCAs) and field safety notices (FSNs):

• FSCAs are undertaken by manufacturers to reduce health risks posed by devices already on the European market.
• FSNs are communications sent by manufacturers to consumers and users in relation to FSCAs.

Furthermore, the guidance states that manufacturers should initiate FSCAs in all markets in which devices in question are commercialized. “Robust and objective” rationales should be provided in cases where a manufacturer decides not to distribute a field safety notice in a particular market.

“It is not sufficient to include in the FSN distribution only countries where adverse incidents have occurred, as the principles of the EU Vigilance System are preventative,” states the guidance.

In addition, FSN content should be “uniform and consistent” for all European Economic Area member states, Switzerland and Turkey where such notices are to be distributed, according to the guidance. In addition, FSN content should neither downplay the level of risk stemming from an incident nor advertise products or services.

Device-specific vigilance

Guidance documents pertaining to vigilance reporting for specific types of devices (cardiac ablation products and coronary stents, so far) has now been compiled on the Commission’s main MDD guidance webpage.

Learn more about medical device vigilance reporting requirements in Europe:

• EU medical device vigilance and incident reporting support
• Whitepaper: EU medical device vigilance reporting requirements

The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt out of designation to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR), with ongoing lack of resolution regarding Brexit continuing to have an impact as well.

Following news last month that UK NB LRQA will cease CE Mark certification services under current Medical Device Directives and not seek MDR or IVDR designation, Swiss NB QS Zurich announced it no longer plans to pursue MDR designation, and will wind down NB operations by October 31, 2019.

UL’s UK-based NB, UL International, will also close shop as of September 1, 2019, but has partnered with Polish NB Polskie Centrum Badan I Certyfikacji (PCBC) so that clients may transfer their CE Mark certifications and maintain European market access.

Different drivers behind NB exits

Two different but hardly exclusive factors drove QS Zurich and UL International to their decisions to end NB support in Europe.

In QS Zurich’s case, MDR designation requirements proved unfeasible. A spokesperson at QS Zurich informed Emergo by UL that they had initially intended to be designated for the MDR. However, the joint assessment audit in December 2018 resulted in serious findings; the company ultimately concluded that it is only possible to handle the deviations “with a disproportionately high effort.” Therefore they will no longer pursue MDR designation. This also means QS Zurich will have to stop their NB activities under the current Directives. They have informed their clients they will no longer support their CE Mark certificates from October 31^st, 2019.

UL International faced a different challenge. Based in the UK, UL International needed to prepare for a no-deal Brexit. In the event that such a scenario comes to pass, British NBs would lose their designations under the current Directives and upcoming Regulations. To mitigate the risk to medical device and IVD manufacturing clients in the event that a no-deal Brexit results in loss of such designation, UL has formed a partnership with PCBC (NB 1434). Through this partnership, UL customers will be transferring their UL CE certificates across to PCBC, ensuring that UL’s NB customers will have continuous certification to enable them to continue to place products on the market and allow continued patient access to these devices. At this time about 80% of UL clients have moved to PCBC, while the remaining 20% have transferred to another EU27 Notified Body.

In addition, UL will retain regulatory experts on staff to provide conformity assessment services to partner EU NBs, as well as support existing and new clients with audits to the Medical Device Single Audit Program (MDSAP), ISO 13485, ISO 14071 and IEC 62304.

Furthermore, UL will for the time being keep their designation to the IVDD for NBOG code 0308 (risk of trisomy 21( incl. software)). Few NBs are currently designated for this code, so UL will keep this designation in place until either all clients with these certificates have transferred to another EU27 NB, or until a no-deal Brexit. A no-deal Brexit scenario would introduce the risk of specific tests no longer being available on the EU market.

More Notified Bodies to follow?

It is far from certain how many additional NBs will cease CE Mark certification services for medical devices and IVDs in Europe. Turkish NBs, for example, will most likely not achieve designation to the MDR in the near term. Other NBs may also come to the conclusion that MDR designation requirements cannot be met in a practically acceptable way.

With only one EU 27-based NB, TÜV Süd,  designated in the EU27 so far (BSI became the first NB designated under MDR, but is based in the UK), many manufacturers remain uncertain about how to maintain their CE Marking. Therefore it is recommended that companies prepare for potentially having to switch their NB relationships. As discussed in Emergo by UL’s whitepaper on changing NBs,  such preparations should include:

• Ensuring technical documentation is up to date and fully compliant with MDR or IVDR requirements;
• Creating a company profile in which NBOG codes, conformity assessment procedures and global presence are summarized;
• Searching in the NANDO database for NBs that match your company profile.

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL in The Netherlands.

Related European medical device regulatory resources from Emergo by UL:

• European CE Marking strategy for medical devices
• On-site MDR training for medical device manufacturers
• European CE Mark consulting for IVDs
• Whitepaper: The new European Medical Devices Regulation
• Whitepaper: Europe’s new In-vitro Diagnostic Medical Devices Regulation (IVDR)

La Commission européenne a publié de nouvelles orientations clarifiant les obligations des fabricants dans le cadre du système de vigilance des dispositifs médicaux établi par la Directive sur les dispositifs médicaux (DDM).

Ce document s'ajoute aux questions couvertes par le document MEDDEV 2.12-1 rév.8, comprenant les rapports d'incident du fabricant, les mesures de sécurité sur le terrain et les avis, ainsi que les recommandations relatives aux rapports de vigilance spécifiques à des dispositifs.

Mise à jour du formulaire de rapport d'incident pour le fabricant

Premièrement, les lignes directrices du document couvrent une version mise à jour du formulaire de rapport d'incident qui deviendra obligatoire pour les fabricants certifiés en vertu de la DDM à compter de janvier 2020.

La déclaration d'incident actualisée comprend le codage et la terminologie fondés sur les recommandations du Forum international des instances de règlementation des dispositifs médicaux (IMDRF), fournit une définition et de nouvelles exigences de formatage pour des incidents similaires à signaler et ouvre la voie à l'utilisation des données SRN et IUD dans ces rapports déclaratifs, qui deviendront obligatoires en vertu de la Directive sur les dispositifs médicaux (DDM).

Définitions, distribution et contenu relatifs à la sécurité sur le terrain

Le document guide établit également une distinction entre les mesures correctives de sécurité sur le terrain (MCST) et les avis de sécurité sur le terrain (AST) :

• Les mesures correctives de sécurité sont prises par les fabricants pour réduire les risques de santé posés par des dispositifs déjà présents sur le marché européen.
• Les avis de sécurité sont des communications envoyées par les fabricants aux consommateurs et aux utilisateurs en rapport avec les mesures correctives.

De plus, le document précise que les fabricants devraient lancer des MCST sur tous les marchés où les produits en question sont commercialisés. Des justifications " solides et objectives " devraient être fournies dans les cas où un fabricant décide de ne pas diffuser un avis de sécurité sur le terrain sur un marché particulier.

« Il ne suffit pas d'inclure dans la distribution des avis de sécurité uniquement les pays où des incidents indésirables se sont produits, car les principes du système de matériovigilance de l'UE sont préventifs », indique le document.

En outre, le contenu des avis de sécurité devrait être "uniforme et cohérent" pour tous les États membres de l'Espace économique européen, la Suisse et la Turquie où de tels avis doivent être distribués, conformément aux orientations du document. De plus, le contenu des avis de sécurité ne doit ni minimiser le niveau de risque découlant d'un incident, ni faire la publicité de produits ou de services.

Vigilance spécifique au dispositif

Les documents d'orientation concernant les rapports de matériovigilance pour des types spécifiques de dispositifs (produits d'ablation cardiaque et endoprothèses coronariennes, jusqu'à présent) ont été réunis sur la principale page Web de la Commission consacrée aux directives DDM.

En savoir plus sur les exigences européennes en matière de rapports de matériovigilance

• Assistanceà la surveillance et à la déclaration d'incident des dispositifs médicaux dans l'UE
• Livre blanc : Exigences de l'UE pour les déclarations de vigilance des dispositifs médicaux

The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards, assisting in understanding article 18 of the Medical Devices Regulation (EU) 2017/745 (MDR).

According to the guidance, implant cards are intended for patients to be able to identify information about devices that is published elsewhere, for example in Eudamed. It is also intended for the patient to identify themselves in case of field safety corrective action (FSCA) or other issue.

Emergency clinical staff or first responders may also use implant cards to obtain information about special care or needs for patients in emergency situations. The implant card must be provided to patients by healthcare professionals, which implies that Member States must draw up specific legislation. Manufacturers are asked to create an informative instruction leaflet to instruct healthcare providers in the use of the implant card, and the effectiveness of these instructions must be verified by a usability study. For ease of use, the implant card should have the same size and shape as a credit card.

Information to be provided

The implant card must clearly identify the device and provide any relevant additional information:

• Device name;
• Serial number or lot or batch number;
• Unique device identification (UDI) in human and machine readable format;
• Name, address and the website of manufacturer;
• Website of the manufacturer;
• Device type.

In addition, the patient and the healthcare provider must be identified on the implant card:

• Name of the patient or patient ID;
• Name and address of the healthcare institution which performed the implantation;
• Date of implantation.

Symbols are allowed to convey this data. Some new symbols are introduced:

• Patient name or patient ID
• Date of implantation
• Name and address of the implanting healthcare institution/provider
• Information website for patients
• Device Name

The symbol for the device name is particularly interesting. It looks like the medical device’s version of the IVD symbol, but apparently this is not the case.

Implantable systems

If a patient is implanted with a set of components that are intended to work together, this is considered an implantable system. Some of these components may later be replaced. The exact components to be implanted may not be known to the manufacturer at the moment the device leaves the place where the implant card is added to the package. This means that system cards require a certain flexibility. A suggestion is made of how a system card could look like, but the guidance document encourages parties involved to look into ways to developing implant cards that fit the specific situation for the system in question.

UDI

Article 18 of the MDR requires the UDI to be represented on the implant card. In the guidance document this is understood as the UDI-DI of the device, both in machine and human readable format. However, article 27 states that a UDI consists of a UDI-DI (the device identifier), plus the UDI-PI (the production identifier). Annex VI, part C, which contains the UDI-related definitions, confirms this by stating that UDI comprises the UDI-DI and the UDI-PI. However, there is a risk that conformity with the guidance document – only the UDI-DI on the card – results in a non-conformity with the MDR. There is a way to meet both requirements: article 18 requires the UDI plus serial number and/or lot number to be on the implant card. This would imply that if the UDI-PI contains the serial number or lot number, the requirement would be fully met by stating the UDI-DI plus UDI-PI.

Summary of Safety and Clinical Performance

One of the three reasons for issuing an implant card is that it allows a patient to identify the summary of a device’s safety and clinical performance in Eudamed. That document is required for all implantable devices, without exceptions. However, the implant card is not required for “simple” implants, sutures, staples, dental filling, etc. This means that manufacturers of the “simple” implants need to provide summaries of safety and clinical performance, while their patients will not be able to identify them. It would have made sense using the same exceptions for both cases. Unfortunately MDCG cannot change the MDR, so for now we have to live with this inconsistency.

Additional European MDR resources from Emergo by UL:

• On-site MDR training for manufacturers
• European MDR gap assessment and CE Mark transition strategy
• Whitepaper: Understanding Europe’s Medical Devices Regulation (MDR)

한국 의료기기 산업 연합체인 한국의료기기공업협동조합(KMDICA)이 500개 이상의 회원사에 유럽 시장 규제 준수 지원을 제공하기 위하여 글로벌 인허가 컨설팅 기업인 Emergo by UL과 파트너를 맺었습니다.

KMDICA와 Emergo by UL 사이에 새로이 체결된 양해 각서(MOU)에 따라, KMDICA 회원사는 해당 컨설팅 기업이 제공하는 다음 서비스를 할인된 가격으로 이용할 수 있습니다.

• 의료기기 제조업체를 위한, 유럽 내 방문이 필요 없는 유럽 공인 대리인 서비스
• 여러 시장에서의 의료기기 등록을 디지털화하여 관리하기 위한 Emergo by UL의 RAMS 추적 서비스로서의 소프트웨어(SaaS)에 대한 무료 접근권
• 2020년 MDR의 발효에 앞선 유럽 의료기기 규정(MDR) 전환 컨설팅 및 격차 분석

또한, Emergo by UL은 한국 내에 전담 프로젝트 책임자를 둠으로써 MOU에 명시된 컨설팅 및 각국 내 대리인 서비스를 KMDICA 회원사에 제공할 예정입니다. KMDICA는 유럽 MDR 준수를 위해 Emergo by UL을 RA/QA 컨설팅 파트너로 선정할 방침입니다.

“한국 의료기기 업계가 점차 수출 지향적인 움직임을 보이고 최신 기술을 도입하는 현 상황에서, KMDICA는 경험이 풍부한 QA/RA 지원을 통해 회원사들이 MDR 요구사항을 준수하고 유럽 시장에 진출하는 과정을 효율화할 수 있다는 사실을 인지했습니다.” Emergo by UL 시장 진출 분과의 디렉터이자 총괄 관리자인 Michael van der Woude의 전언입니다. “Emergo by UL이 한국 의료기기 기업의 유럽 시장 진입을 보조하는 KMDICA의 파트너가 되어 매우 기쁩니다.”

KMDICA에 대해

한국의료기기공업협동조합(KMDICA)은 1979년에 설립된 이래 500개 이상의 한국 의료기기 기업을 회원으로 맞이했습니다. KMDICA는 회원사에 교육, 훈련, 그리고 연구 지원을 제공함으로써 한국 의료기기 산업을 홍보하고 지지합니다.KMDICA에 대해 더 자세히 알아보세요.

Emergo by UL에 대해

Emergo by UL은 글로벌 의료기기와 IVD 규제준수를 전문으로 하는 선도적인 인허가 컨설팅 기업입니다. 종합적인 솔루션으로 인허가 및 상업적인 성공을 달성하고 유지하는 것을 도와드립니다. 6개 대륙에 위치한 사무소를 통해, 실시간 서비스와 현장 전문가를 제공해 드립니다. 귀사를 발전시킬 수 있는 Emergo by UL의 지원 서비스를 확인해보세요.

DEKRA Certification GmbH, NB number 0124, is now designated for the Medical Devices Regulation (EU) 2019/745 (MDR).

DEKRA’s designation is now published in Nando.  DEKRA is the third Notified Body (NB) to be designated, after BSI Assurance UK Ltd and TÜV SÜD Product Service GmbH. BSI is currently not recommended as an NB because of the very high risk of the UK leaving the EU under a no-deal Brexit scenario on October 31^st, so DEKRA is for now the second option for companies who want to certify under the MDR.

Scope of DEKRA’s designation

DEKRA is designated for a broad scope of the NBOG codes under the MDR, but is not a full-scope NB. Manufacturers should therefore verify their needs within the scope for which DEKRA is designated.

In short, DEKRA is designated for Annexes IX (I and II) and XI(A), although not all Medical Device Nomenclature (MDN) Codes are covered by Annex IX(II). Active implantable devices are not in the scope of DEKRA. The same goes for IVF and ART, aesthetic breast implants and devices for ingestion. DEKRA expects designation for the IVDR “soon,” which confirms the company’s ambition for the IVD field.

Certification under the MDR

A DEKRA spokesperson said they hope they can start the first audits for the MDR in November 2019. That is exactly six months before the date of application of the MDR. This does not give much time for companies to be certified as the realistic estimate for these processes is that they take six to nine months.

Too little, too late?

With the designation of DEKRA there are now effectively two NBs designated for the MDR. As of  August 2019, there are nine months to go until the date of application of the MDR. Many devices need MDR certification if they are to be placed on the market after that date. These include reusable surgical instruments, software and devices depending on embedded software, accessories of devices intended for cleaning, disinfecting and sterilizing of medical devices, etc. It is far from certain all these devices can be certified in time, and therefore the availability of devices after May 2020 may be impacted.

Related European MDR and CE Marking information from Emergo by UL:

• EU Medical Devices Regulation (MDR) resource center
• EU MDR gap assessment and CE Marking transition strategy
• MDR training for medical device manufacturers
• Process chart: European MDR CE Marking regulatory requirements

Last week there were already some rumors about Instituto Italiano del Marchio di Qualita S.P.A. (IMQ) being designated for the Medical Devices Regulation (EU) 2017/745 (MDR). Now this designation has been published in Nando. IMQ is the fourth Notified Body (NB) to be designated, after BSI Assurance UK Ltd, TÜV SÜD Product Service GmbH and DEKRA Certification GmbH. Given Brexit-related uncertainties in the UK and their potential impact for BSI, IMQ is for now the third EU-based option for companies who want to certify under the MDR.

Scope

IMQ is certainly not a full scope NB, although they will probably be capable of servicing many companies. Not all active and non-active implantable devices can be certified, and for the two non-active implantable groups (osteo- and orthopedic implants as well as dental implants and dental material), Class III devices are excluded. Most Class III non-active, non-implantable devices are also included. Interestingly for small and highly specialized companies, most available products can rely on Annex X for certification by IMQ. Annex IX and Annex XI are also covered for most product groups.

Currently IMQ is not designated for the IVDD and therefore it is not likely they will be designated for the IVDR soon.

Certification under the MDR

In August IMQ is closed for summer vacations and therefore it was not possible to ask them when they would expect to see the first audits starting. However, from comments from other NBs this may take until November or December of 2019.

First pattern emerges

Looking at the scopes of TÜV SÜD, DEKRA and IMQ, a first pattern regarding availability emerges.

• TÜV SÜD has almost full exclusivity for active implantable devices.
• Available coverage for active non-implantable devices for imaging, monitoring and/or diagnosis and for active non-implantable therapeutic devices and general active non-implantable devices is much better; all three designated NBs can do that.
• For non-active implants the spread is more mixed, and breast implants can only go to TÜV SÜD, and only for the Annex IX procedure.
• Non-active, non-implantable devices are also covered well, although the Annex X procedure is hardly covered for this group of NBs.
• For the codes related to “devices with specific characteristics” the picture is more scattered. MDS 1002 – devices manufactured utilizing tissues or cells of human origin, or their derivatives – is limited to TÜV SÜD and DEKRA only for devices manufactured utilizing human serum albumin (HSA).
• Reusable surgical instruments can be certified by all three European NBs, which is a good thing considering they need to be certified by May 2020.
• Finally, most specific processes and technologies are also covered by all three NBs.

In conclusion: all types of medical devices can now be certified by these NBs, but not for all procedures. Only TÜV SÜD is capable of certifying a manufacturer with a broad scope of devices. For implants the options remain limited.

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

Additional European MDR-related information from Emergo by UL:

• European MDR resource center for medical device companies
• Whitepaper: Understanding the European MDR