Currently, there is only one topic dominating the headlines: Covid 19 – the Corona Pandemic. But amidst all the ever-increasing case numbers, circulations and hamster stories, there was another piece of news that was received with interest by many manufacturers: The postponement of the MDR until 2021. But what exactly is behind this news? A closer look at the EU Commission’s proposal is worthwhile!

On April 3, 2020, the EU Commission published a notice in its virtual press room that, due to the coronavirus pandemic, it is proposing to postpone the effective date of the European Medical Devices Regulation 2017/745 by one year to May 26, 2021. It said this is necessary due to the current needs for vital medical devices but also because of the high burden on national authorities, healthcare institutions and economic operators. But the proposal has not yet been adopted and the postponement has not been conclusively secured. Moreover, it is by no means a matter of postponing all deadlines by one year. The amending regulation to the Medical Device Regulation also has its work cut out for it.

What hurdles still have to be cleared?

The Commission’s proposal is currently going through the EU’s ordinary legislative process. The first reading in the European Council took place before Easter. The Council introduced further amendments to the proposal. There has not yet been a reading and approval by the Parliament, but this was expected for April 16, 2020. However, both the Council and the Commission recommend the adoption of the proposal and point out that this must be done before May 26, 2020, otherwise the directives would be revoked and thus the MDR would enter into force.

Postponed is not canceled!

Those who have so far assumed, based on the headlines, that the Medical Device Regulation in its entirety will now be postponed by one year are mistaken. Strictly speaking, the period of entry into force with all its details will only be shortened by one year – and that at the beginning. Consequently, all those who would already have to undergo a conformity assessment according to MDR in the period from May 26, 2020 to May 26, 2021, but who would not yet be ready for this, can breathe a sigh of relief. However, not all transition periods and expiration dates will also be pushed back by one year, but will remain with the known dates. Individual aspects, such as the UDI introduction, will only be largely postponed by one year. In the worst case, this means that even more manufacturers will have to obtain certification in an even shorter time. The Council’s revised proposal therefore nevertheless provides for willing manufacturers and notified bodies to be able to apply the MDR to the greatest possible extent as early as May of this year.

The following list shows which dates are being postponed – and which are not:

the MDR does not generally apply until May 26, 2021 (Article 123 (2)).

Repeal of the MDD and AIMD, except for requirements on vigilance, record keeping and the exceptions mentioned, will not take place until May 26, 2021 (Article 122)

Manufacturers and notified bodies that wish to obtain MDR certification or notification now may do so earlier- and earlier in this case means before May 26, 2021 (Article 120 (5) and (6))

Cancellation of all Notified Body notifications under MDD or AIMD only by May 26, 2021 (Article 120 (1)).

Establishment of Common Specifications postponed until May 26, 2021 and their effective date from the same date where established in accordance with Article 9 for the non-medical device groups listed in Annex XVI (Articles 1, 17)

Reprocessing only of single-use devices placed on the market by May 26, 2021, and not May 2020, in accordance with Directive 93/42 EEC, or thereafter in accordance with MDR (Article 17)

Publication by the EU Commission of the Communication on the functionality of the EUDAMED database and compliance with related deadlines postponed to March 25, 2021 (Article 34)

Eudamed-related duties and requirements not applicable until May 26, 2021, or 6 months after notice, depending on EUDAMED functionality (Article 123(d))

correspondingly postpone, if applicable, the applicability of individual aspects from Articles 29 and 56 (Article 123(e))

Postponement of the notification to the Commission of the sanctions envisaged by the member states to February 25, 2021 – the member states are thus given more time to prepare (Article 113)

Commencement of clinical trials under MDD or AIMD may take place by May 26, 2021; reporting of serious adverse events and product defects under MDR also need not take place under these trials until May 26, 2021 (Article 120 (11))

Validity of Articles 35 to 50 until 26 May 2021 only valid for notified bodies that have also submitted an application for notification.(Article 123 (3))

The provision by the Commission of scientific guidance on the uniform interpretation of the criteria for the assessment procedures for specified class III and IIb devices is postponed to May 26, 2021.

The following points will not be changed should the amending regulation be adopted by the EU:

No extension of the validity period of certificates according to MDD and AIMD – the expiration date will remain until May 2022/2024 at the latest (Article 120 (2)).

Making available and putting into service of products placed on the market according to MDD or AIM may nevertheless only take place until May 26, 2025 at the latest (Article 120 (4))

No postponement of the deadline for placing the UDI carriers on the device labeling and higher levels of packaging under Article 27 (4) of the MDR (Article 123 (f))

No postponement, but clearer wording is given to the deadlines for placing the UDI on reusable devices depending on their classification (Article 123 (g))

Another unchanged deadline under Article 123 is the application of the Coordinated Assessment Process for clinical trials starting in 2027

Other significant changes made to the Medical Device Regulation by the Commission’s COVID-19 Amendment:

Extension of exemptions from conformity assessment procedures – so medical devices can be placed on the market under the MDR, MDD or AIMD exemptions for the period from the validity of that same regulation until May 25, 2021.

So, a close reading once again reveals old news: it is not worth burying your head in the sand and postponing the work for the transition to MDR. The planned “postponement” of the MDR is primarily intended to ensure the supply of critical medical devices and, in particular, to relieve the current situation for the EU and the member states. Manufacturers must nonetheless have switched to an MDR certificate by the time their MDD/AIMD certificates expire by May 2024. So, clear your head, put the Corona News aside and get to work. We will be happy to provide you with active support.

MDD versus MDR – Basic information on the European Medical Device Regulation

A major difference compared to the previous MDD 93/42 EEC is that the MDR as a regulation has general validity and immediate effect in all EU member states. Thus, with the MDR, there is an optimized uniform regulation for placing medical devices on the market, with a greater focus on product quality and safety. You can find out how all this will be implemented in detail in the following sections.

What does the new Medical Device Regulation entail?

Major changes affect the following areas:

Classification of medical devices

Conformity assessment procedures

Technical documentation

Clinical evaluation / testing

Responsible person

Market surveillance

Reporting obligations

Quality management

Transparency

But what are the changes in detail?

The classification of medical devices has been expanded by some terms and rules, so that some existing products fall into a different/new class. For example, in addition to the previous classes Im (medical device with measuring function) and class Is (medical device with sterile function), there is a new class Ir (reusable surgical instruments). In addition, stand-alone software now often falls into Class IIa or higher under the MDR, whereas it was predominantly classified as Class I under the MDD. Furthermore, products containing or consisting of nanomaterials receive their own rule, and drug delivery products (so-called borderline products) move into focus.

With the changes, conformity assessment procedures now also vary by class. For Class I products, manufacturers can carry out the conformity assessment procedure themselves and only need to involve a notified body under certain circumstances (Class Im, Is, Ir). For the other classes (Class IIa, IIb and III), the involvement of a Notified Body is required. Furthermore, the requirements for placing on the market and the general procedures (other annex numbers) have been changed. What is completely new is that manufacturers of Class I medical devices – and according to the industry association BVMed, these are approx. 70% of the medical devices offered on the market – must now have their own quality management system. This does not have to be certified, but it does have to be up and running by the effective date of May 26, 2020 (or 2021 because of Corona).

Another fundamental point that is changing is the technical documentation. According to MDR, this must now be more precise and has therefore been specified in its requirements (see MDR Annex II and III). Thus, the scope of the technical documentation is significantly larger and all related documents must also be updated regularly.

For clinical evaluations and trials, the MDR specifies how detailed the clinical data must be and of what type and quality. The requirements here have increased significantly. For example, for high-risk products, clinical data must now generally always be collected and evaluated with the medical device being evaluated. If data from competitor products are to be used, their similarity must be demonstrated, and access to the clinical and technical data of the competitor product is required. How this will work in practice remains to be seen – the MDR provides for contracts between manufacturers for this purpose. The evaluation of existing clinical data can be guided by MEDDEV 2.7./1, rev. 4, among others.

A major change is the introduction of the person responsible for regulatory compliance (Article 15). This role corresponds in approach to the safety officer for medical devices according to §30 MPG, which previously existed only in Germany. In comparison, however, the obligation of the responsible person is significantly expanded. Nevertheless, this is an important point that must be realized by every company.

Another focus of the MDR is the area of post market surveillance (PMS) (Chapter VII, Section 1) as well as the general reporting obligations (Vigilance / Vigilance) (Chapter VII, Section 2). In the corresponding chapters of the MDR, specific requirements are described that go beyond those of EN ISO 13485. Of particular importance is a post-market surveillance plan and a corresponding report on this for Class I devices. A periodic safety update report (PSUR) is also required for class IIa, IIb and III devices.

Essential changes in quality management are the requirements of EN ISO 13485:2016, which have been implemented and partly represent additional obligations.

The EUDAMED database contributes to further transparency, as it is accessible to competitors, notified bodies and the public. Annex VI of the MDR details what economic operators must enter into the database. EUDAMED also includes the UDI database (Unique Device Identification). This uniquely identifies each medical device and enables supply chain traceability.

In addition, some products with aesthetic or no medical use are now also covered by the MDR (Annex XVI), which is basically a drastic change. Because in general, the new MDR also brings higher requirements for products with hazardous substances or single-use products.

What do manufacturers in particular have to do right now?

What does the changeover phase look like now?

There are definitely some points that manufacturers should have already worked through. These include, among others:

Training and designation of the “person responsible for regulatory compliance” (Article 15)

Establishment or completion of the QM system (certification according to EN ISO 13485:2016 would also be ideal). The scope of the QM system depends on the risk class of the products, size of the company and other factors.

Structure and content of the technical documentation must be adapted according to the changes of the MDR

Updating the clinical evaluation of all medical devices and, if necessary, conducting clinical trials

Carrying out the necessary market monitoring activities

Implementation of the UDI system in the company and acquisition of the required UDI number ranges

Clarifying whether the previous notified body also wants to be designated under MDR, by when this will be done and whether the company’s certified products will then still fall under the new scope of the notified body

If a former Class I product has now been upgraded: Search for a suitable Notified Body and conclude a certification agreement with it.

After the Medical Device Regulation has come into force, the following points should still be on the agenda:

Carrying out a conformity assessment procedure with a Notified Body (except for Class I products).

Issue of the declaration of conformity

affixing of the CE mark

Registration of the company and the products in EUDAMED

 

Apart from the tasks mentioned above, it is important that you define a plan in your company for the changeover to the MDR and, in doing so, determine the product life cycle of your medical devices. MDD certificates are valid until May 26, 2024 at the most – provided there is no so-called “significant change”, i.e. substantial changes to the product or, for example, a relocation of the production site or the company headquarters. It is therefore important to know which products will be recertified once again under the MDD and which will already/first be approved under the MDR. This also means that there is no “grandfathering”! Even products that have already been approved under the MDD must go through the entire conformity assessment process according to the MDR and fulfill the corresponding requirements of the MDR.

Don’t bury your head in the sand!

All of this may seem like a daunting task at first glance, but don’t bury your head in the sand!

We, seleon gmbh, can help you with the transition from the MDD to the MDR with solutions that are right for your company. This way, May 26, 2020 (and also May 26, 2021, if there is a postponement due to Corona) can come without any worries.

Please note that all information and listings are not intended to be complete, are without warranty, and are for informational purposes only.

Due to the rapidly changing situation in the context of the Covid 19 pandemic, there may be changes in legal or regulatory requirements at short notice, which we are unable to reflect on a daily basis.